WARNING LETTER

Primal Pet Foods, Inc. MARCS-CMS 645467 — February 21, 2023

Delivery Method:: United Parcel Service
Product:: Animal & Veterinary
Food & Beverages

Recipient:: Recipient Name

Timothy Simonds; Recipient Title

CEO; Primal Pet Foods, Inc.; 535 Watt Drive, Suite B
Fairfield, CA 94534-1790
United States

Issuing Office:: Division of Human and Animal Food Operations West V; United States

WARNING LETTER

February 21, 2023

WL 645467

Dear Mr. Simonds:

The United States Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 535 Watt Drive, Suite B, Fairfield, CA 94534-1790 from July 14 through October 11, 2022. This inspection was conducted in response to a Class 1 recall initiated on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula, lot number W10068709, due to the presence of Listeria monocytogenes detected in an FDA surveillance sample.

Our inspection revealed evidence of significant violations of FDA’s 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), 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 Also, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls requirements of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.³

You may find the FD&C Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.

At the close of the inspection, you were issued a Form FDA-483, Inspectional Observations. We received your written response dated November 1, 2022. We have reviewed your response and we discuss your corrective actions below, in relation to each of the noted violations.

Hazard Analysis and Risk-Based Preventive Controls Requirements

Your animal 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 our inspection of your facility, the FDA Investigator observed evidence of significant violations of these requirements including, but not limited to, the following:

1. You did not identify and implement preventive controls to provide assurances that anyhazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1).

Specifically, your firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. Your hazard analysis determined pathogens (Salmonella spp., Listeria monocytogenes, and E. coli O157:H7) are a hazard requiring a preventive control at the following steps: “Inbound Testing,” “Mix Probiotics, Supplements, and Veggies,” and “Outbound Testing.” Your food safety plan identified the following preventive controls for the hazard of pathogens: “Supply Chain: Approved Supplier,” “Probiotics,” and “Outbound Micro Testing.” During the inspection, your firm provided finished product microbial test results for cat and dog food manufactured between August 2021- August 2022 showing 49 products tested positive for Listeria monocytogenes or Salmonella spp. These positive results demonstrate the controls you have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. An indication the controls you implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample (number 1146079) of your pet food, “Raw Frozen Primal Patties for Dogs Beef Formula,” collected from retail on May 24, 2022, resulting in the July 6, 2022, Class I recall described above.

Evaluation of your response:

Your response stated your firm will no longer utilize supplier approval or outbound microbiological testing as preventive controls for pathogens. You identified (b)(4) as the preventive control for frozen products and probiotic inclusion as the preventive control for freeze dried products. Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. Additionally, you added a sanitation preventive control, and you state training will be provided on the new procedures. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide adequate supporting documentation to demonstrate these corrections have been completed and consistently implemented.

2. You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).

Specifically, your reliance on your testing prerequisite program failed to reduce the probability that a nutrient deficiency or toxicity will occur in your pet food in the absence of a preventive control. In your Hazard Analysis at the “Mix Supplements and Veggies” step, you identified and evaluated the potential chemical hazard of the addition of Vitamin D and Thiamin as a significant hazard and determined it did not require a preventive control due to your testing prerequisite program. However, your prerequisite program was either insufficient or you failed to implement it adequately to manage the hazard. Specifically,

a) The lab report numbered 21-124-9881 with a sample received date of April 23, 2021, for the product Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) reported Vitamin D3 levels, based on dry weight, as 3,410 IU/kg. Your firm’s Standard Operating Procedure (SOP), SOP-722, “Sampling Protocol for Thiamine and Vitamin D,” identifies a maximum vitamin D3 level of (b)(4) IU/kg based on dry weight. Your corrective actions inSOP-722 state, “If the levels of vitamin D exceed the requirements the product will be destroyed.” However, your firm distributed the Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) on April 22, 2021. Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have destroyed the food in accordance with SOP-722. Finally, your firm was not consistently testing the finished products for total Vitamin D (D2 and D3) levels, despite the fact that some of your ingredients contain Vitamin D2, which could contribute to elevated levels of Vitamin D in your dog food.

b) Although you told the Investigator that you utilize the AAFCO Food Nutrient Profiles, the table on page 2 of your SOP-722 identified a minimum thiamine level of (b)(4) mg/kg based on a dry weight in feline diets. The AAFCO Food Nutrient Profiles for thiamine in feline diets identifies a minimum level of 5.6 mg/kg. As a result, your prerequisite program is insufficient to manage a thiamine deficiency hazard. For example, the lab report numbered 21-029-9570 with a sample received date of January 14, 2021, for the product Feline Chicken & Salmon Formula Freeze Dried (lot W10022504), reported thiamine levels based on dry weight as 3.96 mg/kg. Your firm distributed the Feline Chicken & Salmon Formula Freeze Dried (lot W10022504) with a low thiamine level on January 11, 2021.Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have reworked the food in accordance with SOP-722, even if you had been aware of a low level of thiamine.

Evaluation of your response:

Your response stated you identified a new third party lab for all chemical testing and your testing method for vitamin D will include both vitamin D2 and D3; SOP-722 will be retired and product sampling, inspection and analysis SOP & guidelines will be updated; the addition of ingredients containing vitamin D and thiamine will be verified by review and sign-off; job cards for all products will be updated with current batch recipe amounts; training will be provided on the new supplement addition process; and your food safety plan and hazard analysis are being reviewed and updated with the assistance of a new food safety consultation company. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide supporting documentation to demonstrate these corrections have been completed and are being consistently implemented.

3. You did not validate that the process preventive control you identified and implemented in accordance with 21 CFR 507.34 is adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facility’s food safety system, as required by 21CFR 507.47(a).

Specifically, your firm adds (b)(4) as a preventive control for pathogens for your freeze-dried products. The FDA reviewed your validation study for the use of (b)(4) as a preventive control for Salmonella in your freeze-dried beef products and we determined your validation study did not support your claim that the probiotic is an effective preventive control for Salmonella. The validation study did not report whether Salmonella was detected below (b)(4) CFU/g. FDA considers even very small amounts of Salmonella in a pet food distributed to consumers to adulterate the food and preventive controls must ensure that animal food will not be adulterated. [See 21 CFR 507.34(a)(1)]. Also, your validation study does not address the other pathogens you have determined to be hazards requiring a preventive control, such as E. coli O157:H7 and Listeria monocytogenes.

Evaluation of your response:

Your response included a revised report of the validation study conducted by (b)(4) for the inhibition of Salmonella using (b)(4) with updated graphs and language. After a review of your revised validation study report, FDA still concludes your study does not support your claim that the probiotic is an effective preventive control for Salmonella in freeze dried, raw beef; therefore, your response is inadequate. Your revised study indicates (b)(4) detection was performed using the “(b)(4)” for Salmonella, following (b)(4) methodology. However, (b)(4) is not an applicable method for your process. Probiotics present in treated freeze-dried raw beef samples contain high levels of background flora which can suppress the growth of Salmonella and decrease the sensitivity of detecting Salmonella. Additionally, although the revised study report references “Selective Enrichment,” you used non-selective (b)(4) and a non-selective (b)(4). Selective enrichment broths for samples with high levels of probiotics help facilitate the growth of Salmonella while also suppressing the growth of the background flora without decreasing the sensitivity of detecting Salmonella. Furthermore, your study report also indicated you performed an enumeration of Salmonella by following FDA’s Bacteriological Analytical Manual (BAM); however, FDA BAM does not have a method for Salmonella enumeration and the method used in the study is not able to detect ˂10 CFU/g of Salmonella.

Your response also provided a protocol for a validation study to be conducted by (b)(4) for using (b)(4) as a preventive control for Listeria monocytogenes in freeze-dried products. You indicated the initial report from (b)(4) would be available in December 2022. We are unable to further evaluate this corrective action until we can review the final study report.

4. You did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, as provided in 21 CFR 507.42(b)(1)(ii), in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan, as required by 507.42(b)(2).

Specifically, on July 6, 2022, your firm recalled Raw Frozen Primal Patties for Dogs Beef Formula, lot W10068709, with a production date of (b)(4), after an FDA surveillance sample of the lot revealed the presence of Listeria monocytogenes. Your preventive controls for the hazard of pathogens were found to be ineffective; therefore, you are required to take corrective action to identify and correct the problem, reduce the likelihood the problem will recur, and evaluate all affected animal food for safety. During FDA’s inspection, our review of your “Grind Line Temperature Inspection” form for (b)(4) line (b)(4) indicated your firm manufactured (b)(4) products before and (b)(4) products after the recalled lot. Your firm does not perform cleaning between batches of the same recipe and only performs a (b)(4) when transitioning between different recipes. Your firm failed to evaluate the safety of the products manufactured on the same date and line as the recalled lot. In addition, your firm failed to reduce the likelihood the problem will recur as evidenced by your testing showing four lots of finished product found positive for pathogens after implementation of your corrective actions in response to the recall.

Evaluation of your response:

Your response stated you are updating your food safety plan to add a sanitation preventive control and will review and update all associated procedures, checklists, and pre-operational instructions. In addition, you are updating your good manufacturing practices and will provide training on your new procedures, increase your environmental monitoring swab sites, and will provide training on your CAPA procedures. You also stated that if any product tests positive on a particular shift, all product manufactured on that shift will be sent for rework. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide adequate supporting documentation to demonstrate the promised corrections have been completed and consistently implemented.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or 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 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” https://www.fda.gov/media/97464/download
• Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
• Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” 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 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 & Drug Administration
HAF Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Or emailed to: orahafwest5firmresponses@fda.hhs.gov.

Refer to the Unique Identification Number (CMS 645467) 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

CC: Matthew Koss, Founder/Chief Product Officer via email @ Matt@primalpetgroup.com

_____________________

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)].