Expert Recall

By Willie Bryant

On October 8, an FDA news release announced that the U.S. Department of Justice, on behalf of the FDA, filed a complaint for a permanent injunction against a California-based ready-to-eat food company, seeking to stop them from manufacturing, producing, and selling adulterated food products. The complaint goes beyond citing the company alone, also naming a company vice-president and two of its managers. This is no slap on the wrist – the manufacturer on the other end of the DOJ’s injunction could be shut down.

This is a severe case where a food manufacturer has had repeated violations and warnings over the past seven years. The FDA and the California’s Dept of Public Health have worked together to shut down this company’s operations as the State has embargoed and seized all in-process and finished products while FDA filed the injunction complaint to prevent further production and sale. Testing by FDA, State, and DOD labs have found Listeria monocytogenes in the production facility or in finished products.

Although no illnesses have been documented, L. mono could cause fatal infections in young children, the elderly, and persons with weakened immune systems. Listeriosis in pregnant women may result in miscarriages or stillbirths.

FDA has consistently taken necessary legal actions against companies and/or products which fail to follow, or to be produced under Current Good manufacturing Practice requirements for foods. In this case, it appears that FDA gave this firm every opportunity to come into compliance and produce safe products. The company’s failure to comply with cGMPs may have irreparably damaged the company and its reputation, With the emphasis being placed on compliance with all FDA regulations, as voiced recently by FDA Commissioner Hamburg, this incident should be a possible wake-up call to other FDA regulated firms.

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