- Delivery Method:
- United Parcel Service
- Animal & Veterinary
Food & Beverages
Recipient NameOlivia Hudson
- OC Raw Dog LLC
1500 Commerce St., Ste. A #101
Corona, CA 92880-1715
- Issuing Office:
- Office of Human and Animal Food Operations- West Division 5
February 23, 2022
Dear Ms. Hudson:
The United States Food and Drug Administration (FDA) inspected your raw dog food manufacturing facility located at 1500 Commerce Street, Ste. A #101, Corona, California from April 16, 2021 through May 26, 2021.
This inspection was conducted in response to a Class I recall initiated on (b)(4) of (b)(4), lot number (b)(4), due to the presence of Salmonella and Listeria monocytogenes (L. mono) detected by the (b)(4). FDA considers this lot of dog food manufactured by your facility to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)] in that it bears or contains an added poisonous or deleterious substance which may render it injurious to health.
The inspection revealed violations of FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements for animal food, 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, the failure to follow the Hazard Analysis and Risk-Based Preventive Controls requirements 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 received your response dated June 10, 2021. After reviewing the inspectional findings and response you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls Requirements
During our inspection of your facility, FDA Investigators noted evidence of violations of the Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in 21 CFR part 507, subpart C.
1. Your hazard evaluation did not include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen, as required by 21 CFR 507.33(c)(2).
Specifically, work-in-process for your raw dog food is exposed to the environment at multiple steps in the production area (e.g., during mix/grind, during movement in open carts, during patty forming) before the final product is bagged and sealed. After sealing, the pet food does not receive any treatment that would significantly minimize pathogens. However, your hazard analysis with issue date of February 1, 2021, does not evaluate environmental Salmonella for this animal food.
Additionally, your hazard analysis concluded that environmental contamination with L. mono from equipment and employees does not require a preventive control due to your facility’s lack of incidence of this hazard and due to your sanitation (b)(4) program. We have concerns with these conclusions, as follows. On April 1, 2021, during the rinsing of manufacturing equipment before cleaning, which is a part of your (b)(4) sanitation procedures, our Investigator observed your employees using water to spray down equipment food-contact surfaces. The equipment’s food-contact surfaces still contained remnants of raw ingredients and the water pressure was enough to create a fine mist and aerosol. Our Investigator observed this fine mist and aerosol enter fans in the processing room, which caused the mist and aerosol to be dispersed throughout the room onto various surfaces, including production equipment. You stated that these fans are cleaned and sanitized (b)(4). Our Investigator observed these fans in use during production on (b)(4), and you stated that the fans are left on during production and sanitation. Aerosols created during cleaning can be dispersed by fans and contaminate clean utensils and equipment. This is an example of a way that environmental pathogens could spread in your facility. As detailed below, FDA sampling found Salmonella Kentucky and Listeria spp. in your facility’s processing environment.
Evaluation of your response:
Your June 10, 2021 response provided updated hazard analysis pages that include the hazard of recontamination with environmental pathogens. You indicated that at the Mix/Grind step you are going to use (b)(4) as a preventive control. You also included various scientific articles on the use of (b)(4). However, we are unable to evaluate your corrective action because you did not provide any information on the use of the (b)(4) in your facility, nor did you provide any validation data or studies on how the (b)(4) would be effective at controlling the hazard of contamination with environmental pathogens for your specific products and process.
When you establish preventive controls for environmental pathogens, you must comply with the environmental monitoring requirements of 21 CFR 507.49. Specific procedures for adequate environmental monitoring are listed in 21 CFR 507.49(b)(3).
2. You did not validate that your preventive control 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 21 CFR 507.47.
Your hazard analysis entitled "PATTY PRODUCTS HAZARD ANALYSIS" for your firm's raw dog food patties identified the biological hazards of Salmonella, L. mono, and E. coli at the chipping step for which you have implemented the Process Preventive Control of the application of (b)(4). The chipping step is where you separate frozen blocks of meat ingredient into smaller pieces prior to grinding. You spray (b)(4) on frozen beef, frozen lamb, frozen raw poultry, and frozen fish (b)(4) chipper. Our investigator observed your employee spraying (b)(4) intermittently (b)(4) during processing.
The validation study that you provided is (b)(4). This study used (b)(4). Your manufacturing process uses frozen lamb, poultry, and fish, in addition to frozen beef. The study examined E. coli and Salmonella, while your pathogen hazards also include L. mono. The study concluded that (b)(4) could be a helpful intervention in beef harvest facilities (e.g., slaughterhouses) against pathogens. Your facility manufactures dog food and your processing does not involve (b)(4) or a (b)(4). The lack of alignment between the study and your processing practices is a reason that the study you presented to validate your (b)(4) preventive control is inadequate for that purpose. Validation is important so that you know that the preventive control you have chosen significantly minimizes or prevents the hazard(s) requiring control.
Evaluation of your response:
Your June 10, 2021 response included scientific articles discussing the use of (b)(4) as a control for pathogenic bacteria. Your use of (b)(4), including the meat it is applied to, should mirror the conditions and applications in the studies in order to use these studies as validation for your preventive control. Your response did not include any validation data or studies specific to the use of (b)(4) in your manufacturing process or animal food products that demonstrate your use of (b)(4) significantly minimizes or prevents bacterial pathogens.
Undesirable Microorganisms in Your Pet Food and Your Processing Environment
Your firm manufactures raw pet food and the practices described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms. 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. (21 CFR 507.3).
On (b)(4), a sample of (b)(4) manufactured at your facility was collected by the (b)(4) and was found positive for Salmonella and Listeria monocytogenes. You recalled this lot on (b)(4).
During the FDA inspection, we performed swabbing for the presence of environmental pathogens. Sample number INV 1134380 consisted of one hundred (100) environmental subsamples (1-50, A-B). The FDA laboratory recovered Listeria innocua in subs 7A, 11A, 18A, 24A, 27A, 34A, 41A, 49A, and 50A. Listeria grayii was recovered in sub 41A. Notably, subsamples 7A, 18 A, and 41A were collected from meat-contact surfaces located in the chipper, grinder, and (b)(4) belt, respectively. Sample number INV 1134381 consisted of forty (40) environmental subsamples (1-40, A-B). The FDA laboratory recovered Salmonella Kentucky in subsample 19B. Listeria innocua was recovered in subsamples 11A, 12A, 19A, 21A, 28A, 32A, and 38A.
The presence of undesirable microorganisms in your finished product and processing environment, including food-contact surfaces, is further evidence of the significance of your violations of the animal food Hazard Analysis and Risk-Based Preventive Controls requirements and demonstrates that your practices are not adequate to prevent or mitigate biological hazards.
We acknowledge your April 30, 2021 response to the FDA environmental sample findings, and June 10, 2021 response addressing the recall of product that was manufactured by your firm. However, recalling product does not prevent the reoccurrence of a hazard in your pet food. It is your responsibility to prevent adulterated product from entering the animal food supply.
This letter is not intended to be an all-inclusive statement of violations that may exist 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. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure, and injunction.
We also have the following comments:
1. In addition to being validated, a preventive control must be implemented properly to comply with 21 CFR 507.34. Our investigator observed that you failed to follow the labeled directions that were your process for the application and monitoring of (b)(4), your purported preventive control for pathogen hazards during chipping.
2. On (b)(4), you performed a recall as described above. Your written recall procedure entitled “Product Withdrawal and Recall”, Section 6.9, dated February 22, 2021, states that “… a summary of the recall will be prepared by the Recall Coordinator. This summary will include a root cause analysis to generate corrective actions”. Additionally, section 8.4 requires that the Senior PCQI may need to include the “Results of investigation into cause of adulteration” in initial and follow up reports for the (b)(3)(A). However, it appears that your firm did not conduct a root cause analysis to determine a possible source and route of contamination. Your June 10, 2021 response did not include any update to your root cause investigation. A root cause investigation is an important step toward addressing the cause of the recall.
3. Your firm’s food safety plan contains elements of a supply-chain program (21 CFR part 507, subpart E) to address L. mono, E. coli, and Salmonella in incoming raw protein ingredients. For example, in your hazard analysis Raw Material Receiving step, you listed “control measures” such as purchasing from approved suppliers and having “Supplier’s Specification and Letter of Guarantee on file”. However, to the extent you intended to implement a supply-chain program, in its current form your program would not meet the requirements of Subpart E and it is not adequate to provide assurance that the pathogen hazards have been controlled by your suppliers.
4. During the inspection, you mentioned to our Investigator that you are considering the use of (b)(4) to reduce pathogens in your pet food products. Please note that your firm must ensure that any additives that are used to reduce pathogens in your raw pet food are the subject of an animal food additive regulation published in 21 CFR Part 573 or are generally recognized as safe for the use (GRAS, as defined by the FD&C Act). Otherwise, your food may be adulterated under section 402(a)(2)(C)(i) of the FD&C Act.
5. Information on animal food and animal food additives can be found at http://www.fda.gov/safefeed
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/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.
• Draft 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.
• 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 within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, 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
Irvine, CA 92612
Refer to the Unique Identification Number CMS 615550 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.
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 FD&C Act [21 U.S.C. § 342(a)(4)] and Title 21, Code of Federal Regulations, section 507.1(a)(1) [21 CFR 507.1(a)(1)]
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)]