As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
G & C Raw, LLC — Versailles, OH
The Food and Drug Administration sent a warning letter dated Dec. 12, 2019, to the owner of G & C Raw LLC, Cathy Manning.
During an inspection at G & C Raw LLC, raw pet food manufacturing facility April 22-25, FDA investigators found serious 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)).
The warning letter says that, “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. The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act.”
In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.
Salmonella and Listeria monocytogenes can cause severe and potentially fatal infections in both animals and in humans. Children, the elderly, pregnant women, and people with weakened immune systems are especially at risk.
People are at risk if they handle the recalled pet foods. Also, surfaces such as freezers, refrigerators, counter tops and pet food bowls can become contaminated and easily infect people.
The violations noted by the FDA:
Current Good Manufacturing Practice (CGMP) Requirement Violations:
- “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 (redacted). The (redacted) and containing raw Beef Veggie and Fruit Dog Food (redacted). Drops of water from (redacted). Employees were also observed stepping over this tote several times as drops of water from their boots fell into the (redacted). The raw dog food re-work in the (redacted) 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 (redacted), 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 (redacted) 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.”
- “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 (redacted). 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 (redacted). The beef hearts had been sitting at room temperature from (redacted) Monday, April 22, 2019, until approximately (redacted) Wednesday, April 24, 2019. Thawing raw meat product at (redacted) for (redacted), 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 (redacted). Thawing raw meat product (redacted), or portions of the ingredients, to reach a temperature that would support the growth of undesirable microorganisms in your animal food.”
- “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:”
- “(redacted) employees lifted a barrel to empty the remainder of the contents into (redacted). 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 (redacted). 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.”
- “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 (redacted) of raw beef heart being used to manufacture product. This can cause (redacted) 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 (redacted). 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 monocytogenes 3 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.”
Corrective Actions:
“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 (redacted), 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 “(redacted)” 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 (redacted), there was no explanation about how your processing practices are changing to adapt to the new equipment. How long will raw material (redacted), who will be monitoring this process and how will material be rotated, for example?”
Additional 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.”
A complete list of the violations can be found in the FDA’s warning letter.
New 88 Japanese Food Trading Inc — Flushing, NY
The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to Mr. Shao Song (Kevin) Chen, president and co-owner of New Japanese Food Trading Inc.
During an inspection at New Japanese Food Trading Inc’s seafood processing facility and importer establishment on Aug. 13, 15, 19, 27, and Sept. 6, 2019, FDA investigators collected environmental samples from various areas in the processing facility, including areas that are near food and food-contact surfaces. The warning letter says that, “FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation [Title 21, Code of Federal Regulations, Part 123 (21 CFR 123)].”
In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA
Presence of L. monocytogenes:
“L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
“FDA laboratory analysis of the environmental sample INV1117726 collected on August 13, 2019, from various areas in your processing facility, including areas that are near food and food-contact surfaces, confirmed that ten (10) of the eighty (80) environmental swabs collected were positive for Listeria monocytogenes and one (1) additional swab was positive for non-pathogenic L. innocua.
“Three (3) of the swabs that were positive for L. monocytogenes were collected from the following food-contact surfaces:”
- “The edge of the upper level of a table (swab # 17) that your firm was using to store unpackaged RTE tuna loins that were exposed to the processing environment;”
- “The black rubber strips (swab # 26) mounted in the middle of the swinging doors that lead from your processing cooler to your storage cooler. Your firm was observed to push a table with unpackaged, RTE tuna loins exposed to the processing environment through these doors. The RTE tuna loins were observed to make direct contact with the black rubber strips; and”
- “The top surface of a cutting board (swab # 38) that your firm reported was used to cut RTE tuna loins prior to sampling.’
“Whole genome sequencing (WGS) analysis was conducted on the ten (10) swabs obtained from INV1117726 that were positive for L. monocytogenes. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. This analysis found two (2) different strains of L. monocytogenes in your facility. Both strains were found on food-contact surfaces (Zone 1), and one (1) of the strains was also found in Zones 2, 3, and 4, indicating cross-contamination in your facility.”
“Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.”
“Your September 27, 2019 response describes intensified environmental sampling being conducted, updating your sanitation procedures, and revising an environmental monitoring program. We will verify the adequacy of your corrective actions during a future inspection.’
Seafood HACCP:
“Your significant deviations are as follows:”
- “You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B:”
- “Design, material, and workmanship of equipment and utensils makes them adequately cleanable (21 CFR 117.40(a)). FDA investigators observed grooves on a plastic cutting board that did not allow for adequate cleaning and sanitizing. Your firm stated during our inspection that this cutting board was used earlier in the day to cut RTE tuna loins.”
- “Conducting food manufacturing, processing, packing, and holding under conditions and controls to minimize the potential for the contamination of food (21 CFR 117.80(c)(2)). FDA investigators observed:”
- “Apparent moldy stains on various surfaces in the processing cooler, including on a folding table, the swinging doors that lead from your processing cooler into the storage cooler, and various other locations in your processing cooler. RTE tuna loins, staged on a table, were observed to make direct contact with these black rubber strips when the employees of your firm pushed the table through the these swinging doors and into your storage cooler.”
- “Apparent grease on the handle of hoses used for cleaning your processing cooler.”
- “Taking effective measures to protect finished food from contamination (21 CFR 117.80(c)(6)). FDA investigators observed:”
- “Condensation from an air-conditioner dripping onto RTE tuna loins that were being stored on a table.”
- “Detergent and water sprayed from a high-pressure hose splashing from the floor to a bucket of uncovered ice and two boxes of uncovered striped bass.”
- “Excluding pests (21 CFR 117.35(c)). FDA investigators observed:”
- “One mouse in the ambient storage area, approximately 3-5 houseflies in the processing cooler, and a spider web near the entrance to the processing cooler.”
- “The gate door of your facility being left open and the plastic curtain leading to the processing cooler missing one strip.”
“Additionally, you must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records required for the processing of RTE tuna loins that we observed on August 19, 2019.”
“We have reviewed the corrections identified in your responses and determined that not all of them appear to be adequate. Specifically, your root cause analysis and corrective action described in your response to address the condensation from the air conditioning system that was observed to drip onto tuna loins does not appear appropriate. Your root cause analysis determined that “condensation was not wiped off immediately,” and your corrective action is to hang a squeegee in the designated location and to use a disposable paper towel to wipe off condensation. This correction does not address protecting food contact surfaces and product from dripping condensation. It was noted during the close-out of the inspection that your firm moved the staging table to the middle of the production room, so it is no longer below the AC unit, and your solution to the condensation problem was to turn on both units. Please clarify regarding how you are addressing condensation and provide an update on the status of this correction.”
“Additionally, your response to the detergent and water that was observed splashing from the floor to the uncovered ice and uncovered striped bass was to replace all hose nozzles. It is not clear how replacing the nozzle will address the observation. Also, continued use of high-pressure hoses does not appear to be consistent with your “Sanitation Handling Techniques, Personal Hygiene Practice and Color Coding Program” procedure which indicates that “(redacted)” and “(redacted).” To prevent aerosols from contacting RTE food, food contact surfaces, and food packaging materials, FDA recommends avoiding the use of high-pressure water hoses during production in areas where RTE foods are exposed or after equipment has been cleaned and sanitized.”
“Your response includes a new sanitation monitoring form; however, it lacks actual monitoring records.”
- “You must implement an affirmative step which ensures that the fish or fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the refrigerated tuna that you imported from (redacted).”
“Your response includes a certificate from the (redacted) Department of Agriculture certifying that the fresh chilled tuna manufactured by (redacted) is “manufactured under the HACCP system for assuring food safety.” However, to comply with 21 CFR 123.12(a)(2)(ii)(B), the certificate must specifically certify the fish or fishery product was processed in accordance with the requirements in 21 CFR Part 123.”
A complete list of the violations can be found on the FDA’s warning letter page.
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