1. Disclaimer: Hello Guest, Doberman Chat Forums presents the opinions and material on these pages as a service to its membership and to the general public but does not endorse those materials, nor does it guarantee the accuracy of any opinions or information contained therein. The opinions expressed in the materials are strictly the opinion of the writer and do not represent the opinion of, nor are they endorsed by, Doberman Chat Forums. Health and medical articles are intended as an aid to those seeking health information and are not intended to replace the informed opinion of a qualified Veterinarian.”
    Dismiss Notice
Dismiss Notice
Hello Guest!
We are glad you found us, if you find anything useful here please consider registering to see more content and get involved with our great community members, it takes less than a minute!

Blue Ridge Beef Warning Letter and other info!

Discussion in 'Nutrition News and Articles' started by strykerdobe, Jul 11, 2020.

  1. strykerdobe

    strykerdobe Hot Topics Subscriber

    Blue Ridge Beef Pet Food Warning Letter
    July 8, 2020

    in Pet Food News

    Blue Ridge Beef Pet Food Warning Letter

    A recently issued FDA Warning Letter to Blue Ridge Beef provides rarely seen transparency and FDA’s same old Enforcement Discretion song and dance.

    The FDA recently published a Warning Letter to Lea-Way Farms Inc. dba Blue Ridge Beef (issued June 26, 2020). The FDA Warning Letter provides pet owners with transparency about the quality of ingredients and conditions at this pet food manufacturer – this FDA Warning Letter provides pet owners with information we deserve to know about every pet food manufacturer.

    The Blue Ridge Beef pet food website states:

    “Our raw materials are sourced from USDA certified and inspected human consumption plants while we also choose to source some meats locally to support our communities; where they are then processed in our state of the art USDA registered and FDA inspected facilities using the same quality control standards as human consumption.”

    The FDA Warning Letter paints a different picture.

    “The U.S. Food and Drug Administration (FDA) conducted an inspection of your raw pet food manufacturing facility at 417 Garden Valley Road in Statesville, NC on September 30, 2019 through October 25, 2019. The investigators documented significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation [Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507)].”


    Of significance and FDA admission that this pet food utilizes ingredients that violate the Federal Food Drug and Cosmetic Act, the Warning Letter continues with:

    “Your firm utilizes tissues from animals that have died otherwise than by slaughter in the manufacturing of pet food without first determining whether the animals suffered any type of illness, injury, and/or whether any medications may have been administered to the animals prior to your pick up from the supplier and subsequent use in manufacturing, such that tissues from the animals would be unsuitable for manufacturing and processing into your pet food.”

    The Warning Letter to Blue Ridge Beef continues with many different concerning issues:

    “On the kill floor, while employees removed hides from three cow carcasses, stomach contents and fecal matter were observed spilling over onto exposed carcasses. We did not observe these carcasses being rinsed before being rolled into the cooler area where the carcasses are further separated for pet food use.”

    “On the kill floor and in the cooler, carcasses were observed being dragged on the floors, dropping from the railing system onto the floors and being trimmed from the floors in these rooms.”

    “The cooler unit in the cooler room was observed to be in poor repair and dripping condensate directly into tubs of open, exposed beef leg bones, shanks, and neck bones used to manufacture pet food.”

    And FDA states that Blue Ridge Beef pet food is not registered with the FDA as required by law. “Our records indicate that as of the date of this letter your registration was canceled. The failure to register a facility is a prohibited act under the FD&C Act.”

    It is a step forward towards pet food transparency that FDA included pertinent information about the quality of ingredients used in this pet food in this Warning Letter. Pet owners deserve to know EVERY SINGLE TIME which pet foods utilize ingredients from diseased animals and animals that have died other than by slaughter. Unfortunately we are rarely told this information. We thank FDA for the transparency here.

    But at the same time – in the very same Warning Letter – the FDA states this (bold added):

    “As noted in our 2019 CVM update (FDA Clarifies Use of Certain Animal-Derived Materials in Animal Food), animal food that is the product of a diseased animal or an animal that has died other than by slaughter is adulterated under section 402(a)(5) of the FD&C Act [21 U.S.C. § 342(a)(5)]. FDA does not intend to enforce this requirement, if the animal food is not otherwise adulterated.”

    Absurd. The above is FDA’s official ‘Okie Dokie’ to the entire pet food industry – FDA telling pet food manufacturers they will allow pet food to utilize adulterated ingredients. Undeniable evidence the FDA Center for Veterinary Medicine could care less about the federal laws they are charged with enforcing.

    As reminder, we asked FDA in 2016 for the science to prove pet food ingredients sourced from diseased animals or animals that have died other than by slaughter are safe for pets to consume (Freedom of Information Act Request 2016-4226). The FDA responded: “After searching our files, we did not find the requested records.” In other words, the FDA has NO science to prove their enforcement discretion allowing illegal ingredients in pet food is safe for pets.

    While we thank FDA for this one disclosure to a pet food’s use of adulterated ingredients, we continue to question why FDA allows all pet foods (excluding Human Grade) to utilize adulterated ingredients with no warning or disclosure to pet owners. We continue to question who you are really interested in protecting…our pets or the waste disposal needs of industry.

    Pet owners can send the FDA an email here: AskCVM@fda.hhs.gov.

    Pet owners can also send their Representatives in Congress an email with link to the FDA Blue Ridge Beef Warning Letter quoting the FDA’s admission to allowing pet food to violate federal law. Link to Warning Letter: Lea-Way Farms Inc. dba Blue Ridge Beef - 597944 - 06/26/2020


    Wishing you and your pet(s) the best,

    Susan Thixton
    Pet Food Safety Advocate
    TruthaboutPetFood.com
    Association for Truth in Pet Food

    [​IMG]

    Become a member of our pet food consumer Association. Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.

    What’s in Your Pet’s Food?
    Is your dog or cat eating risk ingredients? Chinese imports? Petsumer Report tells the ‘rest of the story’ on over 5,000 cat foods, dog foods, and pet treats. 30 Day Satisfaction Guarantee. www.PetsumerReport.com

    Find Healthy Pet Foods in Your Area Click Here

    [​IMG]

    The 2020 List
    Susan’s List of trusted pet foods. Click Here to learn more.
     
    • Like Like x 1
  2. strykerdobe

    strykerdobe Hot Topics Subscriber

    [​IMG]

    The Blue Ridge Beef Controversy

    The Blue Ridge Beef Controversy


    Blue Ridge Beef is a company that sells raw pet food products in the US. According to their website (as of Dec 17, 2017), their products are processed in their own USDA inspected, human grade food facilities, and they sell “100% Pure Meat” with “no additives or preservatives.” Their main facilities are located in Statesville, North Carolina; Eatonton, Georgia; and Bunnell, Florida.[​IMG]

    Concerns have been raised by raw feeders regarding the sourcing and quality of meat used in Blue Ridge Beef products. These concerns are based on the connection of Blue Ridge Beef with another company owned by the same person and listed under the same street address as BRB called Lea Way Farms, Inc. Here is an example of one of many forum posts on this subject.

    “Dead, Dying, Diseased, & Disabled” Meat
    Both Lea Way Farms, Inc. and Blue Ridge Beef are listed under the same owner, street address, and contact information.

    [​IMG]
    Source: NC Department of Agriculture Feed & Pet Food Report
    [​IMG]
    Source: USAOPPS.com
    [​IMG]
    Source: Blue Ridge Beef’s dealer directory
    The Blue Ridge Beef facility located in Bunnell, FL is also listed under a similar name, “Leaway South”.

    Lea Way Farms, Inc. picks up dead, dying, diseased, or disabled (“4D”) cattle from area farms and provides a “means of sanitary disposal.” In this 2006 Iredell county record (on page 6), it is stated that “the existing plant processes useable materials into pet food products.” It goes on to say, “Steven Lea, Applicant, stated that Lea Way Farms has safely removed 28,000 pounds of ruminant material out of Iredell county and surrounding counties […] Mr. Lea stated that there are approximately 50,000 beef and dairy cattle in Iredell County and that the farmers experience mortality of cattle for various reasons including disease, predation, weather events, accidents, etc. Mr. Lea stated that since 1979 his company has collected these animals for recycling”.

    [​IMG]
    Source: the 2006 Iredell county record.
    Lea Way Farms, Inc has an active government contract under which the company is responsible for “ONGOING BOVINE SPONGIFORM ENCEPHALOPATHY SAMPLE COLLECTION OF 3D/4D SAMPLES.” Bovine Spongiform Encephalopathy is a prion disease also known as Mad Cow Disease. 3D/4D refers to dead, dying, disabled, or diseased animals.

    [​IMG]
    Source: a government contract database website.
    False USDA Establishment Number
    Another major concern is the apparently false USDA Establishment number that Blue Ridge Beef has given out to customers. Raw feeders have posted on forums claiming that they were given this false information by the company.

    [​IMG]
    Text from a comment on a topic thread on the Dog Food Advisor message forum.
    I personally asked Blue Ridge Beef for their USDA Establishment Number via email, and I was given the number “2424”. I was unable to verify this number in the online USDA establishment database, so I filed a Freedom of Information request with the Food Safety and Inspection Service (FSIS) asking for access to verification, or lack thereof, of USDA establishment number records associated with Steven Lea, Blue Ridge Beef, and/or Lea Way Farms, or any other business located at the same street address.

    The response to my request stated, “Please be advised that a search by knowledgeable staff in FSIS failed to locate any records responsive to your request.” They indicated that the establishment number “2424” was actually the number for an unrelated company located in Iowa.

    [​IMG]
    The response to my FOI request from the USDA’s FSIS.
    USDA-FSIS only regulates facilities that process food that is safe for human consumption, thus only human grade meat will technically be considered “USDA inspected.” Blue Ridge Beef claims that their food is processed in their own USDA inspected human grade food facilities on their website (as of Dec 17, 2017); however, this is impossible without a valid USDA establishment number.

    It is perfectly legal (and very common) to use 3D/4D meat in pet food products. Feeding 4D products may not be inherently harmful; many raw feeders do so knowingly due to the significant price difference between 3D/4D and human grade meat, and the idea that it can be perfectly safe as long as the company that sources the meat is reliable. Using 4D meat as pet food also prevents it from being wasted. However, it is up to the owner’s discretion to weigh the benefit vs risk and decide what they are comfortable feeding. If a company lies about the source or quality of their products, owners are not able to make that decision for themselves, and may be unknowingly feeding something they are not comfortable with.

    [​IMG]
    This particular seal can be found on K9 Kraving raw dog food as proof of their USDA certification & inspections.
    USDA inspections are not legally required for pet food facilities, but they can be voluntarily inspected. The food will then be labelled with a seal stating “packed under continuous inspection of US Dept. of Agr.”, like the one in the photo to the left of this text. The number on the bottom, “17095”, corresponds to the facility’s establishment number.

    This particular example on the left is for K9 Kraving dog food. This seal can be found on the packaging of their products, and their establishment number can be verified by locating it in the USDA establishment number database. They also have a link to their USDA certification documentation on their website. In comparison, none of this information is made available on Blue Ridge Beef’s website, Blue Ridge Beef products do not have this seal on their product packaging, and (as stated previously) the establishment number given to customers by Blue Ridge Beef representatives cannot be verified in the USDA establishment number database or located by USDA-FSIS employees in response to a FOI request.

    Horse meat
    Another concern that has been raised is that Lea Way Farms has been said to pick up not just cattle, but also dead or dying horses from area farms.

    [​IMG]
    Source: a post in a horse message forum.
    Although horse meat is very nutritious and would be safe to feed as pet food in theory, there are reasons to be concerned over the idea that horse meat may end up in pet food products. Some raw feeders are horse owners and/or would not be comfortable feeding horse meat to their dogs as a personal choice. However, they cannot make that choice for themselves if the company they buy from isn’t completely honest about the content of their products. Horses in the US are rarely safe for human consumption due to vaccinations, medications, or even euthanasia drugs that may be present in the animal’s body at the time of death. Euthanized horses have been used in pet food before: for example, in Feb 2017, some Evanger’s canned dog food products were tested and found to contain horse meat and pentobarbital (euthanasia drug).

    Blue Ridge Beef’s response to customer concerns
    Raw feeders have reported receiving hostile responses after questioning Blue Ridge Beef. According to the owner of the company, they are no longer addressing concerns regarding these issues. Here is a statement released by the owner.

    [​IMG]

    Are Blue Ridge Beef products safe?
    The purpose of this article is to summarize the concerns surrounding Blue Ridge Beef’s pet food products. It is not meant to convince anyone not to purchase these products. Although the correlations and connections detailed in this article seem to strongly suggest that this company is not being completely truthful with their customers, there are also reviews from plenty of loyal customers that choose to feed these products. I have no vested interest in any type of competitor, nor do I stand to gain anything by publishing this information. All of the information in this article is publicly accessible. My intention in writing this article, just like any of my other articles, is simply to inform raw feeders. It is ultimately up to you to decide whether or not you are comfortable feeding this product, and the information provided in this article simply allows you to make a fully informed decision.



    Update: as of March 5, 2018 the death of two kittens has been linked to their consumption of Blue Ridge Beef kitten grind.

    Update #2: In July 2020, the FDA issued a warning letter to Lea-Way Farms, Inc. (dba Blue Ridge Beef) that states: “Your firm utilizes tissues from animals that have died otherwise than by slaughter in the manufacturing of pet food without first determining whether the animals suffered any type of illness, injury, and/or whether any medications may have been administered to the animals prior to your pick up from the supplier and subsequent use in manufacturing,” among other violations.
     
    • Appreciation Appreciation x 1
  3. strykerdobe

    strykerdobe Hot Topics Subscriber

    WARNING LETTER

    Lea-Way Farms Inc. dba Blue Ridge BeefMARCS-CMS 597944 — JUNE 26, 2020

    Lea-Way Farms Inc. dba Blue Ridge Beef - 597944 - 06/26/2020

    WARNING LETTER

    Lea-Way Farms Inc. dba Blue Ridge BeefMARCS-CMS 597944 — JUNE 26, 2020

    Delivery Method:
    VIA UPS
    Product:
    Animal & Veterinary
    Food & Beverages
    Recipient:
    Steven J. Lea
    CEO/Owner
    Lea-Way Farms Inc. dba Blue Ridge Beef
    417 Garden Valley Rd.Statesville, NC 28625-9427United States

    Issuing Office:
    Division of Human and Animal Food Operations East III
    United States

    June 26, 2020

    RE: CMS # 597944

    WARNING LETTER

    Dear Mr. Lea,

    The U.S. Food and Drug Administration (FDA) conducted an inspection of your raw pet food manufacturing facility at 417 Garden Valley Road in Statesville, NC on September 30, 2019 through October 25, 2019. The investigators documented significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation [Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507)]. As a result of these violations, the pet food manufactured in your facility is adulterated in that it is prepared, packed, or held under insanitary conditions whereby it may have been become contaminated with filth or rendered injurious to health.1 The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is prohibited.2 You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.

    At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written response dated November 13, 2019. We have reviewed your response and we discuss your significant violations and your corrective actions below.

    Current Good Manufacturing Practice (CGMP) Requirement Violations

    During our inspection of your facility, FDA Investigators noted violations of 21 CFR Part 507, Subpart B. Violations observed during the inspection include, but are not limited to, the following:

    1. You did not examine your raw materials to ensure they were suitable for manufacturing and processing into animal food, and you did not handle them under conditions that will protect the animal food against contamination and minimize deterioration as required by 21 CFR 507.25(b)(1). Specifically:

    • Your firm utilizes tissues from animals that have died otherwise than by slaughter in the manufacturing of pet food without first determining whether the animals suffered any type of illness, injury, and/or whether any medications may have been administered to the animals prior to your pick up from the supplier and subsequent use in manufacturing, such that tissues from the animals would be unsuitable for manufacturing and processing into your pet food.
    2. You did not construct and maintain your plant in a way that reduces the potential for contamination of animal food as required by 21 CFR 507.17(b). Specifically:

    • The concrete floors of the kill floor (where whole animals are skinned and eviscerated), the cooler room (where carcasses are trimmed and held), and the grinder/mixing room (where pet food ingredients are ground, mixed, and packaged into finished product) are rough and pitted, with standing pools of water. These areas are not easily cleaned, creating a possible niche for undesirable microorganisms.
    3. You did not thaw your raw materials or ingredients in a manner that minimizes the potential for the growth of undesirable microorganisms as required by 21 CFR 507.25(b)(3). Specifically:

    • In your grinder/mixing room we observed thawing beef parts used to manufacture your pet food coming into contact with the concrete floor. As noted in violation 2, the condition of your floors creates a possible niche for undesirable microorganisms that could contaminate the thawing ingredients.
    4. You did not take adequate precautions to ensure that your plant operations do not contribute to contamination of animal food as required by 21 CFR 507.25(a)(5). Specifically:

    • In the cooler, employees were observed performing sanitation procedures. Over-spray from the pressure washer was observed falling into open tubs of exposed meat held for use as pet food.
    • On the kill floor, while employees removed hides from three cow carcasses, stomach contents and fecal matter were observed spilling over onto exposed carcasses. We did not observe these carcasses being rinsed before being rolled into the cooler area where the carcasses are further separated for pet food use.
    • On the kill floor and in the cooler, carcasses were observed being dragged on the floors, dropping from the railing system onto the floors and being trimmed from the floors in these rooms. As noted in violation 2, the condition of your floors creates a niche for microbial activity that could contaminate the carcasses.
    5. You did not maintain holding and conveying systems in a way to protect against contamination of animal food as required by 21 CFR 507.22(b). Additionally, all plant equipment must be designed of such material and workmanship to be adequately cleanable and must be properly maintained as required by 21 CFR 507.22(a)(1). Specifically:

    • The overhead metal rails used to transport meat carcasses between the kill floor, cooler room and processing room were observed to be poorly maintained. When overhead rails were in use, chipping/flaking paint and product buildup was observed. Additionally, these rails are not easily cleanable due to the chipping/flaking paint.
    6. You did not keep your plant physical facilities in good repair to prevent animal food from becoming adulterated as required by 21 CFR 507.19(a). Specifically,

    • On the kill floor, deteriorating, exposed insulation was observed in the ceiling directly over where exposed beef carcasses are trimmed and separated for pet food.
    • The cooler unit in the cooler room was observed to be in poor repair and dripping condensate directly into tubs of open, exposed beef leg bones, shanks, and neck bones used to manufacture pet food.
    7. Your facility does not have plumbing designed, installed, and maintained to properly convey sewage and liquid disposable waste from the plant and to avoid being a source of contamination to animal food or creating an unsanitary condition as required by 21 CFR 507.20(b)(2) and (3). Specifically,

    • The hand washing sinks located on the kill floor and the cooler room did not have adequate plumbing hook-ups to prevent water from running directly onto the floor. As noted above, carcasses used to manufacture pet food are dropped, dragged, and trimmed on these floors.
    The presence of undesirable microorganisms in your pet food is further evidence of your significant CGMP violations. During our inspection, FDA collected final product and raw ingredient samples for microbiological samples. Sample #1098421 consisted of an in-process sample of raw ground beef intended to be used as an ingredient in your firm’s finished product. This sample was found to be positive for Salmonella London Group B1 and generic E. coli. Sample #1098422 of a finished product sample of Blue Ridge Beef Raw Kitten Grind was found positive for Salmonella Agona Group B and Listeria monocytogenes Type One.

    Food Facility Registration

    The FDA has determined that your pet food manufacturing facility located at 417 Garden Valley Road, Statesville, NC is subject to the food facility registration requirements of the Act.3 Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registration every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Our records indicate that as of the date of this letter your registration was canceled. The failure to register a facility is a prohibited act under the FD&C Act.4 As a responsible official of a facility that manufactures/processes, packs, or holds food for animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

    We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm. Registration may be accomplished online at www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number

    Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537.

    This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:

    U.S. Food and Drug Administration
    Food Facility Registration (HFS-681)
    5001 Campus Drive
    College Park, MD 20740

    When completed, the form may be faxed to 301-436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.

    Corrective Actions

    FDA acknowledges that after our inspection the lot of Blue Ridge Beef Kitten Grind related to Sample #1098422 was voluntarily destroyed and the violative lot was not introduced into interstate commerce. In addition, we also acknowledge that on October 25, 2019 you informed the FDA investigator that your food safety system now includes improved receiving procedures to ensure that cattle used to produce your pet food will not contain violative chemical residues or animal drugs. Your response to the Form FDA 483 contained a similar statement. Your corrective actions must ensure that ingredients used in your pet food do not adulterate the food. Please see the comment below about the importance of controlling hazards associated with your ingredients, including using diseased animals or animals which have died otherwise than by slaughter in animal food. We will evaluate this corrective action during our next inspection of your firm.

    FDA also acknowledges the receipt of your firm’s November 13, 2019 response to the Form FDA 483, which included your proposed voluntary corrective actions. These proposed corrective actions included:

    • Improving Environmental Testing Procedures: (b)(4).
    • Improving thawing procedures: (b)(4).
    • Improving Sanitation procedures: (b)(4). Employees will receive Hygiene Training.
    • Improved Storage within the facility: (b)(4) will be provided additional instruction on cleaning them.
    • Proper labeling: Spray bottles containing toxic materials will be properly labeled.
    • Improved plumbing and waste management: (b)(4).
    You also indicated that you are researching methods to address pathogen contamination. You described additional corrective actions which include equipment and utensil cleaning and providing instructions to employees for handling raw material in your facility, such as instructing employees to put any animal food that touches the floor in a container for disposal.

    Your response does not provide enough detail for us to evaluate whether your proposed corrective actions are sufficient to ensure long-term adoption of practices that will ensure your firm consistently meets CGMP requirements. Many of your proposed CGMP corrective actions also lack timeframes for completion. We will evaluate your corrective actions during the next inspection of your firm.

    Conclusion

    The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

    You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

    We also have the following comments:

    As an animal food facility required to register with FDA, you are subject to the requirements of 21 CFR part 507, which takes a proactive approach to preventing hazards. Part 507 requires a firm to: 1) determine what hazards are associated with the type of animal food the firm produces; and 2) to implement preventive controls to address those hazards that require control. As a firm producing frozen, raw pet food, you may decide to consider biological hazards such as pathogenic bacteria and parasites, chemical hazards such as drug residues, and physical hazards such as large bone fragments. In addition, the source of your ingredients may be relevant when you consider hazards that may be associated with your pet food. As noted in our 2019 CVM update (FDA Clarifies Use of Certain Animal-Derived Materials in Animal Food), animal food that is the product of a diseased animal or an animal that has died other than by slaughter is adulterated under section 402(a)(5) of the FD&C Act [21 U.S.C. § 342(a)(5)]. FDA does not intend to enforce this requirement, if the animal food is not otherwise adulterated. Using diseased animals or animals that died other than by slaughter within your pet food could result in adulteration by biological hazards, such as Salmonella, and chemical hazards, such as decomposed tissue and residues from drugs such as pentobarbital (used for euthanasia). Furthermore, ingredients from animals that have died otherwise than by slaughter may have increased risk of pathogen contaminated tissues depending upon the conditions under which they died and how they are processed. For information on FDA’s current thinking about hazard analysis and preventive controls, please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/UCM592870.pdf.

    Even if your firm is a very small business (as defined by 21 CFR 507.3) subject to more limited requirements, you still must attest to FDA that you are implementing preventive controls to address hazards associated with your pet food. (See 21 CFR 507.7.)5 For more information about qualified facilities, see FDA’s guidance, Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, at: Guidance for Industry: Determination of Status as a Qualified Facility.

    In addition, it is important that you optimize your manufacturing practices throughout your facility to help protect against contamination by undesirable microorganisms. The CGMP requirements in 21 CFR part 507, subpart B provide baseline safety and sanitation standards for the manufacturing, processing, packing, and holding of animal food. For more information on CGMPs, please see the FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, CVM Guidance for Industry #235.

    You are adding (b)(4) to your pet food. (b)(4) is the subject of FDA Food Contact Notification (b)(4) for use as an antimicrobial agent in process (b)(4) used in the production and preparation of certain foods. (b)(4) Notification does not cover use as an animal food additive nor is (b)(4) an approved animal food additive under section 409(a)(2) of the FD&C Act. Animal food containing a food additive that is unsafe within the meaning of section 409 is an adulterated animal food. (See section 402(a)(2)(C)(i) of the FD&C Act.)

    There are animal food labeling requirements that are applicable to your Blue Ridge Beef products. For example, section 403(i)(1) and (2) of the FD&C Act [21 U.S.C. § 343(i)(1) and (2)], 21 CFR 501.4(a), and 21 CFR 501.3(b) state how a food must be identified, and its ingredients listed on labels.

    Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete the corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

    Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

    Your written response should be sent to: U.S. Food and Drug Administration, 60 Eighth Street, NE Atlanta, GA 30309, to the attention of Patricia Hudson, Compliance Officer. If you have questions, you may contact Ms. Hudson at 404-253-2221.

    Sincerely,
    /S/

    Ingrid A. Zambrana
    District Director, Atlanta District (GA-NC-SC)
    Program Division Director, Office of Human and Animal Foods- Division III East
    Office of Regulatory Affairs
    U.S. Food and Drug Administration



    Cc: Anita MacMullan, Director
    Food & Drug Protection Division
    North Carolina Department of Agriculture
    1070 Mail Service Center
    Raleigh NC 27699-1070

    ______________________

    1 Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)

    2 Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]

    3 Section 415 of the FD&C Act [21 U.S.C. § 350d]

    4 Section § 301(dd) of the FD&C Act [21 U.S.C. § 331(dd)]

    5 As an alternative, if your facility is in compliance with North Carolina food safety law, you may attest to this fact and provide the required notification to consumers on your pet food label. (See 21 CFR 507.7.)
     
  4. AnnV

    AnnV $ Premium Subscriber $ Hot Topics Subscriber $ Forum Donor $

    Thanks for the info. Awful though it is.

    Do you feed raw Strykerdobe? which brand(s)?
     
  5. strykerdobe

    strykerdobe Hot Topics Subscriber

    Yes We feed My Pet Carnivore
     
    • Appreciation Appreciation x 1

Share This Page