WARNING LETTER
Pet Center, Inc.
MARCS-CMS 621716 —
February 28, 2022
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Philip Mizrahie
Recipient Title
President
Pet Center, Inc.
4105 W. Jefferson Blvd.
Los Angeles
,
CA
90016-4124
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
WARNING LETTER
February 28, 2022
WL 621716
Dear Mr. Mizrahie:
The U. S. 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. Your facility manufactures dog treats, including Bully Sticks (bull pizzles), Chicken Breast Tenders, and various flavors of SuperChews. This inspection was conducted as a follow up to a previous inspection we conducted between June 21, 2021 and July 13, 2021.
Our recent inspection revealed violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls requirements for animal food, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which cause your products to be adulterated.
1
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.
2
Furthermore, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is also a prohibited act.
3
You may find the FD&C 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 (FDA 483). We have received and reviewed your responses, both dated October 21, 2021, and we address your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your pet food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
1. You did not prepare, or have prepared, and implement a written food safety plan, as required by 21 CFR 507.31(a).
You told our Investigator that you had not conducted a hazard analysis for any type of animal food manufactured at your facility and that you have not identified any preventive controls. You stated a consultant was working on your food safety plan, but you did not know when it would be completed. We note that this is a repeat observation from the inspection that was conducted at your facility in June through July of 2021.
Your written food safety plan must include a written hazard analysis, in accordance with 21 CFR 507.31(c)(1), to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a)(1). The hazard analysis must include an evaluation of the biological, chemical, and physical hazards identified in accordance with 21 CFR 507.33(b), to assess the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c).
You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1). Your written food safety plan must include the written preventive controls, in accordance with 21 CFR 507.31(c)(2).
Additionally, your written food safety plan must include all other information required by 21 CFR 507.31(c)(3)-(7).
Your responses to the previous inspection (concluded on July 16, 2021), dated August 7, August 23, August 27, and September 16, 2021, provided anticipated completion dates for the following elements of your food safety plan:
Pest Control Program – September 17, 2021
Sanitation Preventive Control – September 27, 2021
Environmental Monitoring Program – September 27, 2021
GMP (Primary Employee Hygiene Program) – September 27, 2021
Supply Chain Preventive Control Program – October 1, 2021
Recall Preventive Control Program – October 1, 2021
During the most recent inspection, which concluded on October 8, 2021, you did not provide any documentation that these programs were completed or implemented. In your response dated October 21, 2021, you stated that these programs have been completed. We are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating your implementation of these programs. Additionally, you stated that your final food safety plan, including a hazard analysis, would be completed by January 7, 2022. To date, we have not received documentation of your final food safety plan or any updates regarding its completion.
Current Good Manufacturing Practice (CGMP) Requirements
Your pet food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
2. You did not ensure that adequate precautions are taken 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, on September 21, 2021, during the production of your bacon flavored SuperChews, our investigator observed the following:
A. An employee wearing rubber boots—which were worn while walking on the processing room floor soiled with blood and raw animal tissue—stepped into the cooker, onto the food contact surface, and in direct contact with in-process cooked beef backstrap, a SuperChews ingredient.
B. During sanitation, an employee used a high-pressure hose in a manner that caused blood and raw animal tissue present on the processing floor to splash onto cooked, work-in-process SuperChews that had been removed from the ovens to cool. We acknowledge that during the inspection on October 8, 2021, you voluntarily denatured and disposed of the SuperChews contaminated by spray from employees cleaning the soiled floor.
We reviewed your response dated October 21, 2021, which noted that the employee will no longer perform the precleaning activity of walking into the cooker and that products from the dehydrator will be removed when using the high-pressure hose until the building of your “RTE room” is complete. You also stated that your third-party consultant will be conducting additional employee training regarding these issues. We are unable to evaluate the adequacy of your response since you did not provide supporting documentation for your corrective actions.
3. You did not clean and maintain animal food-contact and non-contact surfaces of utensils and equipment and store utensils and equipment as necessary to protect against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials, as required by 21 CFR 507.19(b). Furthermore, in wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have been contaminated, as required by 21 CFR 507.19(b)(2).
Specifically, on September 21, 2021, during the production of your bacon-flavored SuperChews, our investigator observed that an employee used a shovel to scoop in-process cooked beef backstrap into a rolling metal cart. The shovel was stored with its food-contact surface in direct contact with the processing room’s floor and the employee did not clean and sanitize the shovel before use.
We reviewed your response dated October 21, 2021, which noted that your firm has installed hooks to hang the shovels. You also stated that your third-party consultant will be conducting additional employee training regarding this issue. We are unable to evaluate the adequacy of your response since you did not provide supporting documentation for your corrective actions, other than photos of the installed shovel hooks.
4. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against contamination of animal food by pests, as required by 21 CFR 507.19(e).
Specifically, on September 21, 2021, our investigator observed the following inside your facility, in the animal food processing areas, and in an exterior holding area:
A. Animal feces in the meat washing room, approximately five feet from an open screen door.
B. Animal feces in the northeast corner of the receiving area, approximately eight feet from an open forklift loading dock screen door.
C. Your laundry area door is constructed of expanded metal mesh grated panel which allows for pest entry. In addition, the bottom corner of the door has a gap of approximately ½ inch in diameter, which can act as an entry point for pests. Furthermore, a gnawed rodenticide pellet was present along a wall in the laundry room approximately three feet from the door.
D. Flies were present throughout the facility and were landing on raw, in-process bull pizzles and chicken.
E. Woven mesh bags of bull pizzles were stacked against an exterior wall of your plant. Animal feces were present atop one such bag. The woven mesh bags containing the bull pizzles were torn open, with finished product exposed to the outside environment.
We reviewed your response dated October 21, 2021, which stated that you cleaned all pest activity, trapped a possum, repaired gaps, and trained employees to keep the doors closed. Additionally, you stated that you will be working with your contract pest control company on additional fly abatement strategies and updates to your pest control program. We are unable to evaluate the adequacy of your response since it did not contain any supporting documentation of your corrective actions.
Additionally, your response stated that you will discontinue the practice of storing bull pizzles outside the plant when the “RTE room” is complete. However, you have not provided any documentation demonstrating that the product is no longer stored outside the plant or showing that the “RTE room” is complete and in use. Therefore, we cannot evaluate the adequacy of your response. Furthermore, we note that this is a repeat observation from the inspection that was conducted at your facility in June through July of 2021.
5. You did not keep the grounds around your animal food plant in a condition that will protect against the contamination of animal food, as required by 21 CFR 507.17(a).
Specifically, on September 21, 2021, our investigator observed the following outside your facility, in the grounds around your plant:
A. Animal feces were present in at least three distinct locations approximately three feet from the open screen door to the meat washing room.
B. Animal feces were present in two distinct locations within the HVAC unit of the ingredient storage freezer.
C. Apparent rodent nesting material and at least 100 apparent rodent excreta pellets in an air condenser housing approximately three feet from the aforementioned expanded metal mesh grated panel door leading into your laundry area. The desiccated remains of what appeared to be a rodent were present approximately ten feet from the air condenser housing.
We have reviewed your response dated October 21, 2021, which stated that you have added traps outside and cleaned all locations where feces or nesting was observed. We are unable to evaluate the adequacy of your response and will evaluate your corrective action during the next inspection.
6. You did not maintain the animal food contact surfaces of your plant equipment and utensils used in manufacturing, processing, packing, and holding animal food to protect animal food from becoming contaminated, as required by 21 CFR 507.22(a)(4)(iii).
Specifically, on September 21, 2021, our investigator observed the following in your production area:
A. Hook racks used to hang bull pizzles for dehydrating were covered in a rust-like material on the food-contact surface on a majority of the hooks.
B. Plastic clamps used to clamp bull pizzles to dry them into a curled shape were covered in dark brown to green filth material. Additionally, nearly all exposed metal components of the clamps were orange and covered in a rust-like dust.
C. Metal clamps affixed with lead fishing weights used to dry bull pizzles in a straight fashion were covered with residue, rust-colored spots, and flaking metal.
We reviewed your response dated October 21, 2021, which stated that metal clamps containing rust would be removed and that you are working with a third-party consultant to develop and conduct employee training on your new Sanitation Standard Operating Procedures, with additional discussions regarding storage practices. We are unable to evaluate the adequacy of your response since it did not contain any supporting documentation of your corrective actions. Additionally, we note that this is a repeat observation from the inspection that was conducted at your facility in June through July of 2021.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility and in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure, and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at:
https://www.fda.gov/media/97464/download
.
Draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at:
https://www.fda.gov/media/110477/download
.
Draft Guidance for Industry #246, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program, at:
https://www.fda.gov/media/113923/download
.
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 any 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 (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
orahafwest5firmresponses@fda.hhs.gov
Refer to the unique identification number
WL 621716
when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at Rochelle.Blair@fda.hhs.gov or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations West Division 5
__________________________
1
See 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)(ii).
2
See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
3
See Section 301 (uu) of the FD&C Act [21 U.S.C. § 331(uu)].
Content current as of:
04/19/2022
Regulated Product(s)
Animal & Veterinary
Food & Beverages