Evanger's Dog & Cat Food Co MARCS-CMS 518544 — June 29, 2017

WARNING LETTER

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• Recipient: Ms. Holly N. Sher; Evanger's Dog & Cat Food Co; 2210 West 162nd Street; Markham, IL 60428; United States

• Issuing Office: Chicago District Office; United States

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	U.S. Food & Drug Administration Chicago District Office 550 W. Jackson Blvd., Suite 1500 Chicago, IL 60661 Telephone: (312) 353-5863 Fax: 312) 596-4187

 

WARNING LETTER
FY17-HAFE6-01

 

June 29, 2017

 

UPS NEXT DAY
SIGNATURE REQUIRED

 

Ms. Holly N. Sher, President
Mr. Joel A. Sher, Vice President
Evanger’s Dog & Cat Food Company, Inc.
221 Wheeling Road
Wheeling, Illinois 60090

 

The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility located at 221 Wheeling Road, Wheeling, Illinois between January 10, 2017 and
February 14, 2017. The inspection was conducted in response to a consumer complaint that indicated five dogs became sick, with one of the dogs dying, after consuming “Evanger’s Hunk of Beef in Au Jus”
chunk meat product.

 

As a result of inspectional evidence collected during the investigation, including supplier traceback, facility inspection, and samples collected by FDA, we found serious violations of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. You can find FDA regulations and the FD&C Act through links on FDA’s home page at http://www.fda.gov.

 

FDA analysis of your canned chunk meat dog foods, including “Evanger’s - Braised Beef Chunks,” “Evanger’s - Hand Packed Hunk of Beef in Au Jus,” and “Against the Grain - Grain Free Pulled Beef
with Gravy” chunk meat products revealed that the products were contaminated with pentobarbital. This substance causes your animal food products to be adulterated under section 402(a)(1) of the FD&C
Act [21 U.S.C. §342(a)(1)] because they bear or contain a poisonous or deleterious substance which may render them injurious to health. Furthermore, the introduction or delivery for introduction into interstate
commerce of an adulterated food violates section 301(a) of the FD&C Act [21 U.S.C. §331(a)].

 

Pentobarbital sodium is a drug approved for anesthetizing certain animals. However, though unapproved for this use, pentobarbital sodium is often used as a euthanasia agent. There is not a residue
tolerance established for pentobarbital. Therefore, when it is used in food-producing animals, it can render any resulting meat products adulterated. Use of the pentobarbital-contaminated meat product in
animal food can cause serious illness or injury to animals consuming such products.

 

At the conclusion of the January-February 2017 inspection, the FDA investigators issued a six (6) item Form FDA-483, Inspectional Observations, listing violations found at your facility. Two (2) of the most
significant violations are as follows:

 

1) Your low-acid canned dog food product labeled in part “EVANGER’S *** HAND PACKED HUNK OF BEEF AUS JUS ***” and coded “1816E06HB13 *** BEST JUNE 2020” was found by chemical analysis to contain the barbiturate drug pentobarbital.

2) Your low-acid canned dog food product labeled in part “AGAINST the GRAIN *** GRAIN FREE PULLED BEEF with Gravy *** DINNER FOR DOGS *** NET WT 12 OZ ***” and coded 2415E01ATB12 BEST DEC 2019” was found by chemical analysis to contain the barbiturate drug pentobarbital.

 

In addition, further sampling conducted by FDA found pentobarbital in the following finished product lots of pet food:

 

1) Evanger’s Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
2) Evanger’s Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
3) Evanger’s Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
4) Evanger’s Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
5) Evanger’s Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

 

To avoid distributing adulterated products, it is essential that your firm have a system in place to ensure the safety of your processed animal food. Aspects of such a system may include, for example: attaining assurances that the raw meat material received at your facility is from source animals that contain no violative chemical residues, including drugs, and implementing identification and/or other procedures to track the raw meat material from receipt, throughout the manufacturing process, and into the finished products. It is your responsibility to ensure that your overall procedures and systems adequately prevent and control adulteration so that you are not manufacturing and distributing an adulterated product.

 

We acknowledge your voluntary action of conducting a recall for all of your whole beef chunk meat products manufactured between December 2015 and January 2017. In addition, we have received and reviewed your firm’s correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, and 5/23/2017 regarding your corrective actions as discussed below: 

• In your firm’s correspondence dated 5/18/17, it was stated that the contamination was isolated to a specific supplier of beef material and you discontinued doing business with the supplier. However, you did not provide documentation or other evidence to FDA showing that the supplier in question is the only one who supplied the contaminated raw materials that went into all your recalled products. As such, FDA is unable to evaluate the adequacy of this response.
• In your firm’s correspondence dated 5/18/17, it was stated that if any amount of pentobarbital were to be found in any of your ground loaf products, it would be in an amount that a laboratory would deem as being within the possibility of error and well within the range that FDA had previously deemed not be a health or safety concern in pet foods. FDA does not agree with your assessment that the process of grinding will dilute any pentobarbital present in the loaf products to non-detectable or safe levels. The agency notes that there is no tolerance level for pentobarbital in pet food.
• In your firm’s correspondence dated 5/18/17, it was stated that your corrective action includes conducting random pentobarbital tests of finished products prior to shipment into the market to ensure that the raw materials are unadulterated. FDA has concerns about using random finished product testing as evidence that all lots of your finished products are unadulterated. The samples collected by FDA during this investigation demonstrate that pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, random testing of finished product may not be representative of all units of your products. Furthermore, finished product testing cannot mitigate the risk of pentobarbital in your raw material.
• In your firm’s correspondence dated 5/18/17, it was indicated that all current and new suppliers must provide Evanger’s with letters of guarantee for their products. FDA has concerns that relying solely on a quality guarantee may not ensure the safety of the source material used in the production of your finished pet food. You should consider conducting site audits and/or a review of your supplier’s procedures to verify that the supplier has in fact implemented proper controls to prevent the use of contaminated source material as indicated in their letter of guarantee.
• In your firm’s correspondence dated 4/4/17, it was requested to donate the recalled product to an animal shelter. FDA does not agree that analyzing individual units from recalled lots and finding those units negative for pentobarbital contamination provides sufficient assurance that the remaining units are not adulterated. As can be observed in the samples collected by FDA, the pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, FDA does not find it acceptable to donate any recalled products and instead recommends destruction of all remaining units.

Please be advised that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. You are responsible for ensuring that your facility operates in compliance with the FD&C Act and all applicable regulations. The specific violation(s) noted in this letter are symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.

 

You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.

 

In addition to the above violations, we further note the following:

 

During the inspection, your firm could not provide assurances from your suppliers that your raw materials had not been associated with the use of pentobarbital. In addition, your firm could not provide documentation showing the internal traceability of raw materials from receipt throughout the manufacturing process and into the finished product. Therefore, your firm could not definitively determine whether any of your other products contained the beef that went into the recalled products and has no assurances that the pentobarbital contamination could be traced to a single supplier. Please note that your facility will be subject to the CGMPs for food for animals (21 CFR 507, subpart B) beginning September 2017. Animal food that is not manufactured, processed, packed, and held according to CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii)). Some items to remember as you bring your facility into compliance: 

• Management of the establishment must ensure that all operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart (21 CFR 507.25(a)(1)).
• Management of the establishment must ensure adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials (21 CFR 507.25(a)(5)).
• Management of the establishment must ensure all animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food (21 CFR 507.25(a)(8)).
• Raw materials and other ingredients must be examined to ensure they are suitable for manufacturing and processing into animal food (21 CFR 507.25(b)(1)). 

We encourage you to review our draft Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals. This draft guidance provides further explanation and examples about how these requirements can be met. You will find the draft guidance located at:

 

https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.

 

In addition to compliance with the CGMPs, in the future you must also comply with hazard analysis and risk-based preventive controls requirements (21 CFR 507, subpart C and E), unless an exemption applies (21 CFR 507.5). According to these subparts, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards. The PCQI, or designee, must evaluate identified known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control to significantly minimize or prevent the hazard. One type of preventive control is a supply-chain applied control, which would be implemented if a firm were relying on their supplier to control a hazard requiring a preventive control. A supply-chain-applied control must be written, and must include certain verification activities (and documentation of these verification activities). Verification activities may include onsite audits; sampling or testing of the raw material; review of the supplier’s records by the receiving facility; or other appropriate supplier verification activities based on the risk associated with the ingredient or the supplier.

 

Lastly, during the inspection, it was noted that individuals at Evanger’s Dog and Cat Food Company, Inc. are involved in the operation of two other firms, (b)(4), and (b)(4). We note that the new CGMP and hazard analysis and risk-based preventive controls requirements would also apply to any manufacturing, processing, packing, or holding of animal food by these firms unless an exemption applies.

 

Section 743 of the FD&C Act, 21 U.S.C. §379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection, 21 U.S.C. §379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

 

Please notify in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. You should include in your response any documentation, including photographs, of the corrections you have taken or other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time or you cannot complete all corrections within fifteen (15) working days, please state the reason for the delay and include a timetable for implementation of those corrections.

 

Your written response should be directed to:

 

Nicholas F. Lyons
Director of Compliance
Food & Drug Administration
Office of Regulatory Affairs
550 West Jackson Blvd.
Chicago, IL 60661

 

Refer to the Unique Identification Number (Case # 518544) when replying. If you have questions regarding this letter, please contact Mr. Lyons by phone at (312) 596-4220 or via email at
Nicholas.Lyons@fda.hhs.gov.

 

Sincerely,
/s/
William R. Weissinger, M.S.
Chicago District Director
Office of Human and Animal Food Operations, Division 6 East

 

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