Their RESPONSES.. well the FDA had reason to not be happy.. nor should any one feeding it.
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.