- Delivery Method:
- Overnight Delivery
- Animal & Veterinary
Food & Beverages
Recipient NameRyan C. Minch
Recipient TitleOwner and Member
- Raw Advantage Processing LLC
12264 Silver Falls Highway SE
Aumsville, OR 97325
- Issuing Office:
- Division of Human and Animal Food Operations West VI
August 18, 2020
In reply, refer to CMS 593977
Dear Mr. Minch:
The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility at 12264 Silver Falls Highway SE, Aumsville, Oregon, from August 26, 2019, to August 30, 2019. The investigator documented significant 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). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of Part 507 (located in subparts A, C, D, E, and F of Part 507) is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(uu)]. Additionally, the criteria and definitions in 21 CFR Part 507 apply in determining whether an animal food is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. (See 21 CFR 507.1(a)(ii)). The introduction or delivery for introduction into interstate commerce of an adulterated food is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage 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 September 13, 2019, and your e-mail dated November 20, 2019. We have reviewed your responses and we discuss your significant violations and your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls
1. Your firm failed to identify and evaluate each known or reasonably foreseeable hazard 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).
You provided our investigators with a document titled “Raw Advantage Processing***HAZARD ANALYSIS***RAW, GROUND PRODUCT for (b)(4) Processing” and another titled, “Raw Advantage Processing***HAZARD ANALYSIS***RAW, GROUND PRODUCT – with and without ingredients” (for (b)(4) products) as part of your food safety plan. Our review determined that neither of these documents identifies and evaluates all the known or reasonably foreseeable hazards for animal food in your facility.
a. Your written hazard analysis for your raw ground pet food products that do not undergo (b)(4) did not identify or evaluate Listeria monocytogenes as a known or reasonably foreseeable hazard. Raw meat pet food and its ingredients (such as raw poultry, raw fruits and vegetables, and raw milk) are known to be a source of Listeria monocytogenes.
b. Your hazard analysis for products that undergo (b)(4) did not identify or evaluate microbiological hazards from raw goat milk. According to your (b)(4) formula, manufactured on August 8, 2019, the recipe contains “Goats Milk”, which is listed as raw goat milk on the product labeling. Raw milk is known to be a source of a wide range of microbiological hazards (such as Escherichia coli (E. coli), Listeria, and Campylobacter).
Your September 13, 2019, response indicates your food safety plan will be reviewed and acknowledges potential bacteriological risks. However, your response does not include a revised hazard analysis; therefore, we are unable to assess your corrective action. We will verify the adequacy of your corrective actions during a future inspection.
2. 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).
Meat used in your raw, ready-to-eat products, in chunks or after the grinding step, is exposed to the environment at multiple steps (e.g., during (b)(4), during movement in open (b)(4) carts, during grinding, during staging) before the final product is bagged and sealed. As a specific example, during the inspection, open (b)(4) carts containing raw meat in the grinder/mixer room were observed close to the walls, and the raw meat was touching the wall and a hose hanging on the wall. Environmental FDA sample INV1117248, collected during the investigation, yielded isolates of Listeria monocytogenes in six different locations throughout your facility, including the grinder/mixer room. Your packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. However, neither of your hazard evaluations evaluated environmental pathogens.
Your response dated September 13, 2019, outlines the corrective actions you plan to take in response to your failure to identify and evaluate all known and reasonably foreseeable hazards for the animal food manufactured by your facility. Your corrective actions included a review of your food safety plan by your microbiologist and a third-party Preventive Controls Qualified Individual (PCQI). However, you have not provided your revised food safety plan. Therefore, we are unable to assess your promised corrective actions, as we do not have sufficient information. We will verify the adequacy of your corrective actions during a future inspection.
3. Your firm failed to validate that the preventive controls identified and implemented are adequate to control the hazard, as required by 21 CFR 507.47.
Validation, as defined in 21 CFR 507.3, means obtaining and evaluating scientific and technical evidence that your control measure, or combination of control measures, or your food safety plan as a whole, when properly implemented, is capable of effectively controlling your identified hazards (specifically, Listeria monocytogenes, E. coli O157:H7, and Salmonella).
a. In your document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190827, dated August 26, 2019, your firm identifies (b)(4) of materials in chubs or sealed packages as a process control for “BIOLOGICAL Vegetative Salmonella, Listeria, and E. coli growth and toxin production in (b)(4) treated ingredients.” However, your firm does not have adequate validation for your (b)(4) parameters. Specifically, your method for determining the sample size and the use of standard plate count as an indicator of log reduction (instead of inoculation with pathogens or an adequate indicator organism) are inadequate.
b. In your document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190826, dated August 26, 2019, your firm identifies (b)(4) as a process control for E. coli, Salmonella, and Listeria for pet food products that do not undergo (b)(4). The study presented by your firm in support of this process control is (b)(4). (b)(4) is also known as (b)(4). This study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of your process of (b)(4).
You also provided what appears to be an unpublished study entitled, “(b)(4).” This study uses (b)(4) cubes of beef that are (b)(4) for (b)(4) minutes. This differs from your process, which includes (b)(4) ground meat as it enters the (b)(4).
Your September 13, 2019, response states you will conduct new validation studies for (b)(4) that will include statistically valid sample sizes and inoculation of known quantities of various pathogens to substantiate a (b)(4) reduction. Further, an email received from you on November 20, 2019, states that you have scientific evidence showing (b)(4) reduction kill rates for the (b)(4) and will conduct a validation study to prove the log reduction under manufacturing conditions at your plant. We will assess the adequacy and implementation of your validation study during the next FDA inspection.
4. Your firm failed to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1). Preventive controls include controls at critical control points and at other points that are appropriate for animal food safety. (See 21 CFR 507.34(a)(2).)
Your document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190826, dated August 26, 2019, identified a (b)(4) as a preventive control for certain biological hazards. However, biological hazards may be reintroduced during further manufacturing (e.g., mixing, (b)(4)) or when the animal food is exposed to your manufacturing environment after the (b)(4). As noted above, environmental sampling found pathogens in your facility. Without a food safety plan that controls biological hazards at all critical control points and other points appropriate for animal food safety in your manufacturing process, your preventive controls are insufficient to ensure the biological hazards are significantly minimized or prevented.
In your September 13, 2019 response, you stated your firm will include the (b)(4) of all raw meat and poultry as a preventive control for the bacterial hazards. Additionally, your e-mail dated November 20, 2019, stated that you started working on the validation and implementation of (b)(4) for all raw frozen diet products. While we acknowledge this corrective action, your response did not provide a revised food safety plan with changes in your manufacturing process and did not include adequate documentation for us to fully evaluate your responses. We will verify the adequacy of your corrective actions during a future inspection.
Undesirable Microorganisms in Pet Food and Your Processing Environment
Your firm manufactures pet food and many of the circumstances described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms for which you have inadequate 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.)
On August 27, 2019, FDA collected a sample of (b)(4) Beef Recipe lot (b)(4) (sample 1117252) that was manufactured on August 26, 2019. FDA laboratory analysis of this sample identified the presence of non-O157, Shiga Toxin-producing E. coli O88:H25. FDA conducted whole genome sequencing (WGS) analysis on the E. coli O88:H25 found in your pet food product. As discussed with you on October 18, 2019, the results revealed several virulence markers in the genome suggesting it is pathogenic.
During the FDA inspection, we also performed swabbing for the presence of environmental pathogens. Sample number INV 1117248 consisted of one hundred (100) subsamples of environmental swabs (18) and sponges (82). The FDA laboratory recovered Listeria monocytogenes from 7 of 37 subsamples analyzed for this pathogen. FDA conducted WGS analysis of the L. monocytogenes strains found in environmental sample number 1117248. As discussed with you on October 18, 2019, the WGS analysis found that the L. monocytogenes strain in subsamples 23, 30, and 31 (cart wheel, drain near mixer, and drain near grinder, respectively) of the environmental sample is related to a strain found in (b)(4) in 2016. (b)(4).
On (b)(4), the Minnesota Department of Agriculture (MDA) collected a sample of (b)(4)”, identified as “(b)(4). The sample (MDA Sample Number # (b)(4)) was analyzed by the MDA Microbiology Laboratory and tested positive for Salmonella Dublin. We discussed the MDA test results and FDA’s WGS analysis results with you on November 6, 2019 and February 27, 2020, respectively.
The presence of undesirable microorganisms in your finished product and processing environment is further evidence of the significance of your violations of the animal food hazard analysis and risk-based preventive control requirements and demonstrates that your practices are not adequate to prevent or mitigate biological hazards.
We acknowledge that your November 20, 2019, email indicated that you had completed QA retraining for sanitation methods and areas to target based on FDA swab results.
You reported that the changes made to your cleaning methods and programs are improving sanitation results.
This letter is not intended to be an all-inclusive list of the 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 address this matter may result in legal action without further notice, including, without limitation, seizure and/or injunction.
1. 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 (GRAS, as defined by the FD&C Act). Otherwise, your food may be adulterated under 402(a)(2)(c)(1) of the FD&C Act.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Mark Babbitt, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421.
If you have any questions regarding this letter, please contact Mark Babbitt at 509-353-2136 ext. 107.
Miriam R. Burbach
Program Division Director