On February 28, the United States Food and Drug Administration (FDA) approved Pet Center, Inc. issued a warning letter after a follow-up inspection of a California dog chew facility revealed various violations of the FDA’s current Good Manufacturing Practices, hazard analysis, and . Risk based preventive control requirements for animal feed. Some observations included apparently rusty meat hooks, insect feces on prepared dog bags, or blood and raw meat on finished dog chews. The FDA gave the company 15 days to provide feedback on what specific steps the facility staff would take.
Excerpts from the letter:
The US Food and Drug Administration (FDA) inspected your pet treat manufacturing facility located at 221 Hindry Ave., Inglewood, CA, between September 21, 2021 and October 8, 2021. ), Chicken Breast Tenders, and various flavors of Superchews. This inspection was conducted as a follow up to the previous inspection conducted by us between June 21, 2021 and July 13, 2021.
Our recent inspection revealed a violation of the FDA’s current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Control Requirements for Animal Food, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), of which The reason your products are adulterated…
Your pet food facility is subject to the risk analysis and risk-based preventive control requirements found in 21 CFR Part 507, Subsections A, C, D, E, and F. During an inspection of your facility, FDA investigators noted evidence of significant violations. These requirements included, but were not limited to, the following:
1. You have read 21 CFR 507.31(a)…
2. You have not ensured that adequate precautions are taken so that the operation of the plant does not contribute to contamination of animal food, animal food-contact surfaces and animal-food packaging materials, as by 21 CFR 507.25(a)(5) Necessary.
Specifically, on September 21, 2021, during the production of your bacon-flavored Superchew, our investigator observed the following:
a. A worker wearing rubber boots—which were worn when walking on a processing room floor stained with blood and raw animal tissue—in the cooker, on the food contact surface, and in direct contact with the in-process cooked beef backstrap, a Superchew material.
B. During sanitization, a worker used a high-pressure hose to spray blood and raw animal tissue on the processing floor onto cooked, work-in-process superchews that were removed from the oven to cool. was. We acknowledge that during the inspection on October 8, 2021, you voluntarily removed superchews contaminated with dirty floor cleaning staff spray.
3. You did not clean and maintain animal food-contact and non-contact surfaces of utensils and equipment as necessary to protect against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials Storing utensils and tools. Required by 21 CFR 507.19(b)…
Notably, on September 21, 2021, during the production of Your Bacon-Flavored Superchews, our investigator observed an employee use a shovel to process a beef backstrap cooked in a rolling metal cart. The shovel was stored with its food-contact surface in direct contact with the floor of the processing room and the employee did not clean and sanitize the shovel prior to use.
4. You have not taken effective measures as required by 21 CFR 507.19(e) to exclude pests from manufacturing, processing, packing and holding areas and to protect against contamination of animal feed by insects.
Specifically, on September 21, 2021, our investigator observed the following inside your facility, in the animal food processing areas, and in the outdoor holding area:
a. Animal feces in the meat wash room, about five feet from an open screen door.
B. Animal feces in the northeast corner of the receiving area, about eight feet from an open forklift loading dock screen door.
c. The door to your laundry area is made of expanded metal mesh grated panels that allow insect penetration. In addition, there is a gap of about inch in diameter in the bottom corner of the door, which can act as an entry point for pests. In addition, a munching rodenticide tablet was present along a wall about three feet from the door in the laundry room.
D. Flies were present throughout the facility and landing on raw, in-process bull pizzelles and chicken.
e. Woven mesh bags of Bull Pizzles were placed against the outer wall of your plant. Animal feces were present on top of one such bag. Woven mesh bags containing Bull Pizzles were torn, finished products exposed to the external environment…
5. You did not place the grounds around your animal food plant in a condition that would protect against contamination of animal food as required by 21 CFR 507.17(a).
Specifically, on September 21, 2021, our investigator observed the following in the grounds around your plant, outside your facility:
a. Animal feces were present in at least three different places, about three feet from the open curtain door to the meat-washing room.
B. Animal feces were present in two different locations within the HVAC unit of the ingredient storage freezer.
c. Clear rodent nesting material and at least 100 clear rodent feces pellets in an air condenser housing about three feet away from the above expanded metal mesh grated panel doors leading to your laundry area. The dried remains of what appeared to be rodents were present about ten feet from the air condenser housing.
6. You did not maintain the contact surfaces of your plant equipment and utensils used in the manufacture, processing, packing and keeping of utensils to prevent contamination of animal food, as per 21 CFR 507.22(a)(4) )( iii).
Specifically, on September 21st, 2021, our investigator observed the following in your production area:
a. The hook racks used to hang Bull Pizzles for dehydrating were covered in a rust-like material on the food-contact surface on most hooks.
B. Plastic clamps are used to dry the bull pizzelles into a curled shape, which is covered with a dark brown to greenish dirt. Additionally, almost all of the exposed metal components of the clamp were orange and covered in rust-like dust.
The metal clamps glued to the lead fishing weights used to dry C. Bull pizzelles were covered with residue, rust-colored spots, and flaky metal.