- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameCathy J. Manning
- G & C Raw, LLC
225 N. West Street
Versailles, OH 45380
- Issuing Office:
- Office of Human and Animal Foods Operations East
Warning Letter 586288
December 12, 2019
Dear Ms. Manning:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your raw pet food manufacturing facility at 225 North West Street, Versailles, OH on April 22-25 and May 17, 2019. The investigator 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 raw pet foods manufactured in your facility are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.1 The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act.2 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written responses dated May 21, 2019. We have reviewed your responses and we discuss your significant violations and your corrective actions below.
Current Good Manufacturing Practice (CGMP) Requirement Violations
1. You did not handle work-in-process and rework in such a way that it is protected against contamination and the growth of undesirable microorganisms, as required by 21 CFR 507.25(c)(3). Specifically, our investigator observed:
• An employee used (b)(4). The (b)(4) and containing raw Beef Veggie and Fruit Dog Food (b)(4). Drops of water from (b)(4). Employees were also observed stepping over this tote several times as drops of water from their boots fell into the (b)(4). The raw dog food re-work in the (b)(4) to be made into product. These practices could contribute to the contamination of your animal food with undesirable microorganisms or other contaminants, such as dirt or other foreign material, that may be present on the floor, employee footwear, the dustpan, or other non-food contact surfaces.
• An employee lifted a barrel of ingredients from the floor and placed the barrel directly on (b)(4), the remainder of the ingredients. The barrel was resting on its side, directly on top of raw meat and organ ingredients. This practice could contribute to the contamination of your animal food with undesirable microorganisms or other contaminants, such as dirt or other foreign material, that may be present on the outside of the barrel.
• An employee placed a box of bone meal ingredient on top of a trash can that was being used to throw away containers that had fallen on the floor and raw ingredients, such as fat, that had not met quality standards. The employee scooped bone meal out of the box that was sitting on the trash can (b)(4) raw meat and organ ingredients. This presents the potential to put contaminants into the box of bone meal instead of the trash can, or to accidentally take something out of the trash can to put into the animal food being manufactured.
2. You did not conduct thawing of your frozen ingredients in manner that minimized the potential for the growth of undesirable microorganisms, as required by 21 CFR 507.25(b)(3). Specifically:
• You stated that the frozen raw beef hearts that were used to make raw Beef Veggie and Fruit Dog Food were set out at ambient temperature on Monday, April 22, 2019, at approximately (b)(4). On Wednesday, April 24, 2019, the investigator observed the beef hearts were used to make raw Beef Veggie and Fruit Dog Food and the final finished product went into the freezer at approximately (b)(4). The beef hearts had been sitting at room temperature from (b)(4) Monday, April 22, 2019, until approximately (b)(4) Wednesday, April 24, 2019. Thawing raw meat product at (b)(4) for (b)(4), or portions of the ingredients, to reach a temperature that would support the growth of undesirable microorganisms in your animal food.
• You reported that frozen raw meat, including beef, turkey, chicken, pork, and rabbit used to make your raw dog and cat food products, is (b)(4). Thawing raw meat product (b)(4), or portions of the ingredients, to reach a temperature that would support the growth of undesirable microorganisms in your animal food.
3. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against the contamination of animal food, as required by 21 CFR 507.14. Specifically, on April 24, 2019, while watching the manufacturing of raw Beef Veggie and Fruit Dog Food, our investigator observed the following employee practices:
• (b)(4) employees lifted a barrel to empty the remainder of the contents into (b)(4). One employee grabbed the bottom of the barrel, which had been directly on the floor, with their gloved hand to dump it. The employee then used the same gloved hand that had been touching the bottom of the barrel to spread raw meat ingredients in the (b)(4). The employee did not change gloves or wash their hands between touching the bottom of the barrel and the raw meat ingredients.
• An employee was observed using their cell phone in the processing room while weighing open containers of raw Beef Veggie and Fruit Dog Food. The employee used their gloved hand to touch the raw dog food but did not change gloves or wash their hands after touching their cell phone.
4. You did not take adequate precautions so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials as required by 21 CFR 507.25(a)(5). Specifically, our investigator observed the following operations:
• An employee picked up empty containers that had fallen on the floor on their side and placed them on the cart with other empty containers. The containers that had fallen on the floor were then filled with finished raw dog food product. As employees pick-up the empty containers they could touch the floor and the inside of the containers, introducing undesirable microorganisms and foreign material to the inside of the containers.
• An employee was (b)(4) of raw beef heart being used to manufacture product. This can cause (b)(4) to spread contamination around the processing area, including onto ingredients and animal food-contact surfaces.
• An employee was seen washing a van in the parking lot of the facility with a hose that was connected to a sink in the processing room. The hose was pulled back into the processing room and used (b)(4). This can introduce contaminants into the processing area from the parking lot, where they can be transferred to animal food, food-contact surfaces, and packaging materials.
Your firm manufactures raw pet food and many of the practices described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms for which you have no control. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated. (See 21 CFR 507.3.)
The presence of undesirable microorganisms in your pet food and your processing environment is further evidence of the significance of your CGMP violations. On April 25, 2019, FDA collected sample number 1106962, which included (b)(4) unopened plastic containers, weighing 1 lb. each, of finished Raw Ground Turkey Dog Food. FDA analysis of the Raw Ground Turkey Dog Food product (#1106962) identified Listeria monocytogenes3 in five of (b)(4) subsamples and in one of two composite samples analyzed for Listeria.
During the FDA inspection, we also performed swabbing for the presence of environmental pathogens. Sample number INV 1071173 consisted of (b)(4) environmental swabs. The FDA laboratory recovered Listeria innocua and Listeria grayi in one subsample. The presence of non-pathogenic Listeria species, such as Listeria innocua and Listeria grayi, is indicative of environmental conditions within your production facility that are suitable for the survival and/or growth of Listeria monocytogenes.
We acknowledge that you performed recalls to remove specific lots of Ground Turkey Dog Food and Turkey Veggie Fruit Mix Dog Food from the market in response to our April 2019 sampling.
Further, we acknowledge receipt of your two e-mail messages on May 21, 2019, responding to the Form FDA 483. One e-mail contained a copy of an advertisement for a hand-washing sink you advised us you had ordered, without any indication of when it would be installed or how personnel would be instructed to use it. The other e-mail explained that one employee had been fired, listed some training you had conducted, mentioned that (b)(4), that a paper towel dispenser had been installed, and that a separate hose had been purchased for use cleaning vehicles outside. Some photographs were included, as well, although aside from the paper towel dispenser, it is difficult to identify what these photographs are showing and their relevance.
Although we appreciate this information, these responses do not provide enough detail for us to evaluate whether your response is sufficient to ensure long-term adoption of practices that will ensure your firm consistently meets the CGMP requirements. For example, your response
included the statement “(b)(4)” but you did not include any information explaining which food safety and handling procedures were discussed, or what your expectations for your employees now are. Likewise, although you (b)(4), there was no explanation about how your processing practices are changing to adapt to the new equipment. How long will raw material (b)(4), who will be monitoring this process and how will material be rotated, for example?
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:
Previous Instance of Undesirable Microorganisms in Your Facility’s Pet Food
Undesirable microorganisms have previously been found in your finished raw pet food products, indicating an on-going problem. In 2018, the Ohio Department of Agriculture (ODA) collected samples of finished pet foods stored in your freezer. The ODA laboratory identified Listeria monocytogenes in Ground Chicken Dog Food, Ground Lamb Dog Food, and Pat’s Cat Ground Turkey Cat Food. Salmonella spp.4 was recovered in Ground Chicken Dog Food and Chicken Veggie and Fruit Dog Food.
We acknowledge that you performed recalls to remove these products from the market when they were found in 2018.
Preventive Controls Requirements
Although not covered during the April/May 2019 inspection, as of September 17, 2018, you are required comply with the hazard analysis and risk-based preventive controls requirements for animal food (21 CFR part 507, subparts C and E), unless an exemption applies (21 CFR 507.5). To comply with the preventive controls requirements, you must develop and implement a food safety plan. Specifically, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards for each type of animal food produced at your facility. The PCQI, or designee, must then evaluate the known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control, and you must implement preventive controls to significantly minimize or prevent those hazards. Preventive controls are subject to management components as appropriate to ensure their effectiveness. Salmonella and Listeria monocytogenes are known or reasonably foreseeable hazards in raw meat pet food. For FDA’s current thinking on the hazard analysis and risk-based preventive controls requirements for animal food, you may refer to our draft guidance: Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 corrective actions within fifteen working days, state the reason for the delay and the time frame 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 FD&C 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 non-compliance 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 non-compliance 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, 6751 Steger Drive, Cincinnati, OH 45237 to the attention of Stephen J. Rabe, Compliance Officer or via email to email@example.com. If you have questions, you may contact Mr. Rabe at 513-679-2700, extension 2163.
Steven B. Barber
Director, Division 5
Office of Human and Animal Foods Operations East
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 Listeria monocytogenes is a known animal and human food pathogen. It can proliferate in food processing facilities and be transferred to the food. Exposure to Listeria monocytogenes can lead to a severe, sometimes life-threatening illness in humans and pets. For more information on Listeria monocytogenes, see https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis.
4 Salmonella is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. For more information about the health risks associated with Salmonella in animal food, see Compliance Policy Guide 690.800, Salmonella in Food for Animals, available at https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf.