Commitment Method:
VIA UPS
Product:
Brute & Veterinary
Nutrient & Beverages
Recipient:

Recipient Proper name

Steven J. Lea

Recipient Title

CEO/Owner

Lea-Way Farms Inc. dba Blue Ridge Beef

417 Garden Valley Rd.
Statesville, NC 28625-9427
United States

Issuing Function:
Division of Homo and Animal Food Operations East 3

Us

June 26, 2020

RE: CMS # 597944

WARNING LETTER

Dear Mr. Lea,

The U.Due south. Nutrient 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, Function 507 (21 CFR Role 507)]. As a result of these violations, the pet nutrient 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 wellness. i The introduction or commitment for introduction into interstate commerce of whatever nutrient that is adulterated or misbranded is prohibited. two Y'all may find the Federal Nutrient, Drug, and Cosmetic Human activity and FDA's regulations through links on the FDA'due south website at www.fda.gov.

At the shut of the inspection, yous were issued a Form FDA 483, Inspectional Observations. We received your written response dated Nov 13, 2019. We accept reviewed your response and nosotros talk over your significant violations and your cosmetic actions below.

Current Good Manufacturing Practice (CGMP) Requirement Violations

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

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

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

ii. You did non construct and maintain your plant in a way that reduces the potential for contamination of animal food every bit required past 21 CFR 507.17(b). Specifically:

  • The concrete floors of the kill flooring (where whole animals are skinned and eviscerated), the libation room (where carcasses are trimmed and held), and the grinder/mixing room (where pet food ingredients are ground, mixed, and packaged into finished production) are rough and pitted, with standing pools of water. These areas are non 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 past 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 flooring. Equally noted in violation 2, the condition of your floors creates a possible niche for undesirable microorganisms that could contaminate the thawing ingredients.

four. You did not take adequate precautions to ensure that your plant operations do not contribute to contagion of fauna nutrient as required past 21 CFR 507.25(a)(5). Specifically:

  • In the cooler, employees were observed performing sanitation procedures. Over-spray from the pressure level washer was observed falling into open tubs of exposed meat held for utilize every bit 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. Nosotros did non discover these carcasses being rinsed before existence rolled into the libation area where the carcasses are farther separated for pet food utilize.
  • On the kill flooring and in the libation, carcasses were observed beingness dragged on the floors, dropping from the railing system onto the floors and being trimmed from the floors in these rooms. Equally noted in violation 2, the status of your floors creates a niche for microbial activity that could contaminate the carcasses.

v. You lot did not maintain holding and conveying systems in a way to protect confronting contamination of animal food every bit required by 21 CFR 507.22(b). Additionally, all establish equipment must be designed of such cloth and workmanship to be adequately cleanable and must be properly maintained as required past 21 CFR 507.22(a)(ane). Specifically:

  • The overhead metallic track used to send meat carcasses between the kill floor, cooler room and processing room were observed to exist poorly maintained. When overhead rails were in employ, chipping/flaking pigment and production buildup was observed. Additionally, these rails are not easily cleanable due to the chipping/flaking paint.

6. Y'all did not keep your plant physical facilities in proficient repair to prevent fauna food from condign adulterated as required by 21 CFR 507.19(a). Specifically,

  • On the kill floor, deteriorating, exposed insulation was observed in the ceiling direct 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 straight into tubs of open, exposed beef leg bones, shanks, and neck bones used to industry pet food.

seven. Your facility does not accept plumbing designed, installed, and maintained to properly convey sewage and liquid dispensable waste material from the establish and to avert existence 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 libation room did not have acceptable plumbing hook-ups to prevent h2o from running straight onto the flooring. Equally 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 bear witness of your meaning 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 basis beef intended to be used as an ingredient in your business firm'southward finished product. This sample was found to be positive for Salmonella London Grouping B1 and generic E. coli. Sample #1098422 of a finished production sample of Blueish Ridge Beef Raw Kitten Grind was constitute 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 Route, 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 catastrophe on December 31 of each even-numbered twelvemonth. Our records indicate that every bit of the date of this alphabetic character 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 articles/processes, packs, or holds nutrient for creature consumption in the United states, y'all are responsible for ensuring that your overall operation and the products yous distribute are in compliance with the constabulary.

We request that the owner, operator, or agent in charge of this facility, or an private authorized past this facility'southward possessor, operator, or amanuensis in accuse, register the facility with FDA within xxx 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 achieved online at www.admission.fda.gov. We strongly encourage the use of electronic registration considering information technology will result in an automatic confirmation of registration and automatic issuance of a registration number

Alternatively, the owner, operator, or amanuensis in charge of this facility, or an private authorized by the facility's possessor, operator, or amanuensis in charge, may register the facility past postal service or fax (east.yard., if you do non have reasonable access to the Internet) using FDA's nutrient facility registration form, Form 3537.

This grade 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.Due south. Food and Drug Administration
Food Facility Registration (HFS-681)
5001 Campus Drive
Higher Park, Doctor 20740

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

Corrective Deportment

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 improver, we also acknowledge that on Oct 25, 2019 you lot informed the FDA investigator that your nutrient safety system now includes improved receiving procedures to ensure that cattle used to produce your pet nutrient will not contain violative chemical residues or beast drugs. Your response to the Class FDA 483 independent a similar statement. Your cosmetic actions must ensure that ingredients used in your pet food practice non adulterate the food. Please see the comment beneath about the importance of decision-making hazards associated with your ingredients, including using diseased animals or animals which take died otherwise than by slaughter in creature nutrient. We volition evaluate this corrective activeness during our next inspection of your business firm.

FDA besides 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 cosmetic actions included:

  • Improving Ecology Testing Procedures: (b)(4).
  • Improving thawing procedures: (b)(four).
  • Improving Sanitation procedures: (b)(iv). Employees will receive Hygiene Training.
  • Improved Storage inside the facility: (b)(four) volition be provided additional instruction on cleaning them.
  • Proper labeling: Spray bottles containing toxic materials will be properly labeled.
  • Improved plumbing and waste direction: (b)(4).

You likewise indicated that you lot 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 every bit instructing employees to put any animate being food that touches the floor in a container for disposal.

Your response does non provide enough particular for us to evaluate whether your proposed corrective actions are sufficient to ensure long-term adoption of practices that volition ensure your house consistently meets CGMP requirements. Many of your proposed CGMP corrective actions as well lack timeframes for completion. We will evaluate your cosmetic deportment during the next inspection of your business firm.

Decision

The violations cited in this alphabetic character are non 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 in a higher place and for preventing their recurrence or the occurrence of other violations. Information technology is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

Yous 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 as well have the following comments:

As an animal food facility required to register with FDA, you lot 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) make up one's mind what hazards are associated with the type of fauna nutrient the house produces; and ii) to implement preventive controls to address those hazards that require control. Equally a house producing frozen, raw pet nutrient, you lot may decide to consider biological hazards such as pathogenic bacteria and parasites, chemical hazards such as drug residues, and physical hazards such as big bone fragments. In addition, the source of your ingredients may be relevant when y'all consider hazards that may be associated with your pet nutrient. 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-animate being-food), animal nutrient that is the product of a diseased animal or an beast that has died other than by slaughter is adulterated nether section 402(a)(5) of the FD&C Human activity [21 U.S.C. § 342(a)(5)]. FDA does non intend to enforce this requirement, if the brute food is non otherwise adulterated. Using diseased animals or animals that died other than past slaughter within your pet nutrient could consequence in adulteration past biological hazards, such as Salmonella, and chemical hazards, such as decomposed tissue and residues from drugs such every bit pentobarbital (used for euthanasia). Furthermore, ingredients from animals that have died otherwise than past slaughter may have increased run a 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 assay and preventive controls, please encounter FDA'due south typhoon Guidance for Manufacture #245, Hazard Assay and Run a risk-Based Preventive Controls for Nutrient 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) bailiwick to more than 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 data most qualified facilities, see FDA'south guidance, Conclusion of Status equally a Qualified Facility Nether Office 117: Current Expert Manufacturing Practice, Hazard Analysis, and Take a chance-Based Preventive Controls for Man Food and Part 507: Current Expert Manufacturing Practice, Hazard Analysis, and Gamble-Based Preventive Controls for Food for Animals, at: https://world wide web.fda.gov/regulatory-data/search-fda-guidance-documents/guidance-industry-determination-condition-qualified-facility.

In addition, it is important that you optimize your manufacturing practices throughout your facility to help protect against contamination past undesirable microorganisms. The CGMP requirements in 21 CFR part 507, subpart B provide baseline prophylactic and sanitation standards for the manufacturing, processing, packing, and belongings of fauna nutrient. For more information on CGMPs, please see the FDA's Guidance for Industry #235, Electric current Good Manufacturing Practice Requirements for Food for Animals, https://www.fda.gov/regulatory-data/search-fda-guidance-documents/cvm-gfi-235-current-good-manufacturing-practice-requirements-food-animals.

Y'all are adding (b)(4) to your pet food. (b)(iv) is the subject of FDA Food Contact Notification (b)(iv) for employ equally an antimicrobial agent in process (b)(4) used in the production and preparation of certain foods. (b)(4) Notification does not cover use every bit an animal food additive nor is (b)(4) an canonical animal food additive under department 409(a)(2) of the FD&C Act. Brute food containing a food additive that is unsafe within the pregnant of section 409 is an adulterated animal food. (See section 402(a)(ii)(C)(i) of the FD&C Act.)

There are animal food labeling requirements that are applicative to your Blue Ridge Beef products. For instance, section 403(i)(one) and (2) of the FD&C Act [21 UsC. § 343(i)(1) and (2)], 21 CFR 501.iv(a), and 21 CFR 501.iii(b) land how a nutrient must exist identified, and its ingredients listed on labels.

Within xv working days of receipt of this letter, please notify this office in writing of the specific steps that yous have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, besides equally copies of related documentation. If you cannot complete the corrective action within 15 working days, land the reason for the delay and the fourth dimension within which you volition consummate the correction. If you do non believe that your products are in violation of the FD&C Act, include your reasoning and whatever supporting data for our consideration.

Department 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to embrace FDA'southward 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 nutrient condom 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 connectedness with FDA'south 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 political party for the domestic facility. The inspection noted in this alphabetic character identified noncompliance materially related to a food safety requirement of the FD&C Act. Appropriately, FDA may assess fees to embrace whatsoever reinspection-related costs.

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

Sincerely,
/S/

Ingrid A. Zambrana
District Director, Atlanta District (GA-NC-SC)
Programme Sectionalisation Director, Office of Human and Animate being Foods- Division III Eastward
Office of Regulatory Diplomacy
U.Southward. Food and Drug Administration

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

______________________

1 Section 402(a)(4) of the Federal Food, Drug, and Corrective Act (FD&C Act) [21 U.s.C. § 342(a)(4)] and 21 CFR 507.i(a)(1)

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

3 Department 415 of the FD&C Act [21 U.Due south.C. § 350d]

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

5 Every bit an culling, 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 characterization. (See 21 CFR 507.seven.)