Darwin’s Responds to FDA Warning

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After several recalls over E. Coli and salmonella, as well as multiple customer complaints the FDA says it received, the FDA has issued a Warning Letter to Arrow Reliance Inc., dba Darwin’s Natural Pet Products. The letter, sent on April 2, 2018, formally notifies the company of violations of the law and to request voluntary compliance, according to the FDA.

According to the letter, the FDA conducted an inspection of Arrow Reliance’s raw pet food manufacturing facility in Tukwila, Washington, on December 6 through 7, 2017, and January 25, 2018. During those visits, “the FDA investigators collected samples of a number of raw pet food products from… the manufacturing facility,” as well as from customers. “Analysis of these raw pet food products revealed they were contaminated with salmonella, listeria, and/or shiga toxin-producing Escherichia coli O128,” the FDA stated.

The FDA’s letter to Arrow Reliance went on to say the following:

“It is therefore essential that your firm has a food safety system in place to prevent and control contamination of your products and facility. Aspects of such a system may include: proper implementation and review of cleaning and sanitization procedures, review and/or testing of your incoming materials and outgoing products, review and/or testing of your facility and environment for possible contamination, a kill step to destroy microorganism contamination, and root cause investigation and corrective action procedures when problems arise. It is your responsibility to ensure that your procedures and overall system adequately prevent, control, and respond to contamination so that you are producing an unadulterated product.

“You should take prompt action to correct 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 further regulatory action, such as seizure and injunction, without further notice.”

A representative from the FDA told Pet Age that the firm has 15 business days from the time the letter was received to notify the FDA “to describe (and provide documentation for) the specific steps it has taken to correct the noted violations and to prevent these violations from recurring or other similar violations from occurring.”

Jay Goldstein, vice president of Marketing for Darwin’s Natural Pet Products, told Pet Age the company has been working closely with the FDA since Darwin’s initiated the voluntary recall at the end of March.

“Since that time, we’ve been taking steps to address the specific issues raised by the agency. In fact, we responded to the FDA with a detailed plan prior to the agency issuing its letter to us. We believe our response arrived on the day the FDA issued its directive,” Goldstein said. “We will continue to be in close contact with the FDA, demonstrating to them that we are not only meeting the agency’s expectations but exceeding them.”

Goldstein also pointed out that, “contrary to published reports, Darwin’s Natural Pet Food has not received any customer complaints tied to pet health related to this recall.”

“Over the past year, Darwin’s has received more than 300 customer complaints—regarding everything from late delivery to payment issues. In the past year, we’ve delivered tens of thousands of shipments to customers. We consider the relatively small percentage of complaints to be a testament to our dedication to customer service.”