- Delivery Method:
- VIA UPS
- Animal & Veterinary
Food & Beverages
Recipient NameSteven J. Lea
- Lea-Way Farms Inc. dba Blue Ridge Beef
417 Garden Valley Rd.
Statesville, NC 28625-9427
- Issuing Office:
- Division of Human and Animal Food Operations East III
June 26, 2020
RE: CMS # 597944
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.
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.
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 (https://www.fda.gov/animal-veterinary/cvm-updates/fda-withdraws-outdated-compliance-policy-guides-use-certain-animal-derived-materials-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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-235-current-good-manufacturing-practice-requirements-food-animals.
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.
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.)