WARNING LETTER
Agila Corporation dba Woody’s Pet Food Deli
MARCS-CMS 670835 —
January 26, 2024
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Enrique A. Palma
Recipient Title
Owner
Agila Corporation dba Woody’s Pet Food Deli
105 W. Kraft Road
West Saint Paul
,
MN
55118
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
Secondary Issuing Offices
United States
January 26, 2024
WARNING LETTER
Refer to CMS 670835
Dear Mr. Palma:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility located at 1245 Trapp Road, Suite 160, Eagan, Minnesota, on August 29 through September 12, 2023, in follow-up to an Untitled Letter issued to you on September 2, 2022.
During the inspection FDA collected a sample (FDA sample #1214888) of your in-process Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24, from your facility. FDA laboratory analysis revealed this product was contaminated with Salmonella Reading and Listeria monocytogenes. Based on the analytical results, FDA considers the sampled product lot to be adulterated in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.
1
On September 19, 2023, you voluntarily disposed of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24.
Also, during the inspection FDA’s investigators found evidence of a significant violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21,
Code of Federal Regulations
(21 CFR), Part 507, which causes your raw pet food products to be adulterated.
2
Furthermore, you are using the unapproved/unsafe animal food additive peroxyacetic acid (PAA). Use of an unsafe food additive causes a food to be adulterated.
3
The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.
4
You may find the 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 acknowledge your written response dated September 25, 2023. We reviewed your response to the noted violations and address your corrective actions below.
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 our inspection of your facility FDA investigators observed evidence of a significant violation of these requirements:
You failed to take measures, which are adequate to prevent adulteration of your animal food during the manufacturing, processing, packing, and holding of animal food, to significantly minimize or prevent the growth of undesirable microorganisms in your animal food, as required by 21 CFR 507.25(c)(2). Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate the animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated (21 CFR 507.3).
Specifically, your firm uses
(b)(4)
, an acetic acid, PAA, and hydrogen peroxide
(b)(4)
, as your method to eliminate pathogens from your raw pet food products. On August 31, 2023, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24, which subsequently tested positive for
Salmonella
Reading and
Listeria monocytogenes
. This sample was taken after the application of
(b)(4)
and immediately prior to finished product packaging. Therefore, your use of
(b)(4)
is not adequate to prevent adulteration of your animal food.
FDA previously found undesirable microorganisms in your finished raw pet food products, indicating a recurring issue at your firm. A sample of your Woody’s Pet Food Deli Raw Cornish Hen Homemade Cat and Dog Food with Supplements, collected by FDA on November 30, 2021, tested positive for
Salmonella enteritidis
(FDA sample #1150234). In addition, your Woody’s Pet Food Deli Raw Chicken Homemade Cat and Dog Food collected by FDA on August 20, 2019, tested positive for
Salmonella
Infantis and
Salmonella
Kentucky (FDA sample #1046805).
Evaluation of your response:
Your response stated that use of PAA is a meat processing industry standard approved by the U.S. Department of Agriculture (USDA) and is
(b)(4)
and efficient ways of eliminating pathogens. You provided three scientific studies on the use of PAA as an antimicrobial during processing of raw poultry which were found on the internet.
USDA does not regulate pet food.
5
Regarding human food, USDA considers
(b)(4)
at certain levels to be safe and suitable for use as an antimicrobial agent for the water used in processing, e.g., rinsing, meat and poultry consistent with Food Contact Notification No. 1389 to the FDA.
6
Food contact substances are not intended to have a technical effect in the food.
7
You also responded that you are unable to eliminate pathogens completely. This is a concern because
Salmonella
is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Infections can be especially serious in young children, elderly people, and others with weakened immune systems. The association between human illness or outbreaks of salmonellosis and
Salmonella
-contaminated pet foods is well established.
8
In 2019,
Salmonella
Reading was found in three lots of your Woody’s Pet Food Deli Raw Free Range Turkey and was implicated in part of a human illness outbreak investigated by the CDC.
9,10
Association between
Salmonella
-contaminated pet food and pet illness has also been shown.
11
Thus, FDA considers a pet food to be adulterated if it is contaminated with
Salmonella
.
You have been previously informed on other occasions of the FDA’s position regarding
Salmonella
in pet food, including in an Untitled Letter issued to your firm on September 2, 2022, and in teleconferences between FDA and your firm on August 30, 2019, and December 16, 2021.
Your response is inadequate in that it did not propose changes to your process or add additional interventions to address the recurrence of
Salmonella
in your pet food.
Use of Peroxyacetic Acid (PAA)
During our inspection you provided the labeling and technical data sheet for
(b)(4)
, which your firm uses as an antimicrobial treatment/kill step during processing of your raw meat pet food products. PAA is one of the substances that is in
(b)(4)
. Our investigators noted you use a
(b)(4)
at a concentration of
(b)(4)
ppm for
(b)(4)
for all organ meat and a
(b)(4)
at a concentration of
(b)(4)
ppm for
(b)(4)
on all meat during production.
Any substances that may become part of your pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the Act, or be otherwise not objectionable for use in animal food by definition in the Association of American Feed Control Officials (AAFCO) Official Publication. Although peroxyacids are permitted for use as an antimicrobial secondary direct food additive on certain meat products intended for human food (21 CFR 173.370), there is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Parts 582 or 584 as a substance that is GRAS for the intended use. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. Under section 409(a) of the Act, 21 U.S.C. § 348(a)(2), an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated.
12
Evaluation of your response:
Your firm’s response stated “We can lower the PAA concentration for non-poultry to around
(b)(4)
ppm…” and you provided three scientific studies found on the internet on the use of PAA as an antimicrobial during processing of raw poultry.
Your response is inadequate in that it did not provide any information indicating your use of PAA in pet food is considered GRAS by qualified scientific experts.
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 cause of any violation and for preventing its 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 action including, without limitation, seizure and injunction.
We also offer the following comments:
1. In response to discussion with our investigators about the condition and your use of a wooden butcher block table during production, your response described actions you plan to take regarding this issue. Your response states metal or plastic boards are unsuitable for chopping meats and the butcher block tables are National Sanitation Foundation approved and food grade. Additionally, you stated that even though your butcher block table was relatively new, you would replace it with a new one. You also stated you thoroughly wash, clean, and sanitize after
(b)(4)
. FDA’s concern with the use of wooden tabletops is they are porous, can be damaged during chopping, and are not easily cleanable. Therefore, the wooden butcher block table may serve as a source of contamination with environmental pathogens. Animal food-contact surfaces must be maintained to protect animal food from being contaminated and should be replaced when necessary so that the animal food does not become contaminated.
2. Your facility appears to meet the definition or a qualified facility in 21 CFR Part 507 and, therefore, may be subject to the modified preventive controls requirements in 21 CFR 507.7. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility, 21 CFR 507.7(a)(1). In addition, a qualified facility is required by 21 CFR 507.7(a)(2) to submit one of the following attestations to FDA:
An attestation that you have identified the potential hazards associated with the animal food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that your facility is in compliance with State, local, county, tribal, or other applicable non-federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate State agency (such as a State department of agriculture), or other evidence of oversight.
During the inspection you indicated that you submitted the qualified facility attestations via mail, but you were unable to provide documentation to substantiate this statement. As of the date of this letter, FDA does not have on file a qualified facility attestation form (Form FDA-3942b) for your firm.
We encourage electronic submission of your qualified facility attestation form (Form FDA-3942b) found at https://www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation. If you submit your form via mail, please include a copy of your submitted qualified facility attestation form with your firm’s response to this letter.
(b)(3)(A)
For more information regarding qualified facilities, see FDA’s guidance, “Determination of Status as a Qualified Facility under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” at https://www.fda.gov/media/125438/download.
For more information about FDA’s current thinking on the CGMP 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.
Within 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 15 working days, state the reason for the delay and the timeframe within which you will complete the correction. If you believe that you have complied with the Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, MN 55401, to the attention of Compliance Officer Lauren Sanger. If you have questions you may contact Ms. Sanger at email Lauren.Sanger@fda.hhs.gov.
Sincerely,
/S/
CAPT Chris van Twuyver
Program Division Director, West Division 1
Office of Human and Animal Food Operations
__________________
1
See section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(1).
2
See section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), and 21 CFR 507.1(a)(1)(ii).
3
See section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i).
4
See section 301(k) of the Act, 21 U.S.C. § 331(k).
5
USDA’s voluntary certified pet food provisions were withdrawn in 2022 because the regulations were out-dated and no companies were using the service, and because FDA has had regulatory authority over pet food since 1938. See 87 Fed.Reg. 30773 (May 20, 2022).
6
See FSIS Directive 7120.1, Rev. 58 (June 1, 2023), Table 2, available at https://www.fsis.usda.gov/sites/default/files/media_file/2021-09/7120.1_table_2.pdf.
7
The Act, section 409(h)(6), 21 U.S.C. § 348(h)(6).
8
Fod example, see the Centers for Disease Control and Prevention information on past Salmonella outbreaks related to pet food: https://www.cdc.gov/salmonella/pet-treats-07-19/index.html (pig ear dog treats), https://www.cdc.gov/salmonella/dog-food-05-12/index.html (dry dog food), and https://www.cdc.gov/salmonella/2007/pet-food-9-4-2007.html(dry dog food).
9
Outbreak of Multidrug-Resistant Salmonella Infections Linked to Raw Turkey Products | Multidrug-Resistant Salmonella Infections Linked to Raw Turkey Products | July 2018 | Salmonella | CDC: https://www.cdc.gov/salmonella/reading-07-18/index.html.
10
State Issues Consumer Advisory for Woody’s Pet Food Deli Raw Free Range Turkey Pet Food – MN Dept. of Health: https://www.health.state.mn.us/news/pressrel/2019/salmonella012819.html.
11
https://www.cdc.gov/healthypets/keeping-pets-and-people-healthy/pet-food-safety.html; https://www.avma.org/resources-tools/avma-policies/raw-or-undercooked-animal-source-protein-cat-and-dog-diets.
12
See section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i).
Content current as of:
03/05/2024
Regulated Product(s)
Animal & Veterinary
Food & Beverages