Dated June 29, 2017 – FDA issues a Warning Letter to Evanger’s Pet Food stating “we found serious violations of the Federal Food, Drug, and Cosmetic Act.”
The FDA website explains a “Warning Letter” as follows: “When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.”
On June 29, 2017 – FDA issued a Warning Letter to Evanger’s Pet Food in reference to inspection between January 10, 2017 and February 14, 2017 – prompted by the death of a pet and illness of multiple others. The FDA Warning Letter states “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.”
The Warning Letter explains the violations of law, and explains the troubling issues the agency still has with Evangers…
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.
The FDA Warning Letter scolded Evanger’s Pet Food for lack of proper record keeping…
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.
And the agency made clear that prompt action must be taken…
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.
To read the full FDA Warning Letter, Click Here.
Wishing you and your pet(s) the best,
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