On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks to prevent S. Serra Cheese Company, based in Clinton Township, Michigan from receiving, preparing, processing, packing, holding, or distributing food until they meet FDA requirements. The Complaint for Permanent Injunction comes as a result of inspectional observations and the Company’s failure to take prompt action when notified of these observations. In particular, FDA inspected the manufacturing facility in 2013 and found bacteria in its finished products and manufacturing facility that could cause potentially devastating harm to humans. They also found violations of monitoring and sanitations controls found in the “Good Manufacturing Practice” requirements for foods (21 CFR Sec. 110). The FDA’s announcement may be accessed here.
After the inspection, on June 6, 2013, the FDA issued a warning letter to the Serra Cheese Company, which can be found here. The FDA Warning Letter laid out the findings of the FDA visit to the plant along with the numerous violations. It also asked the company and its owners to respond within 15 working days to describe in detail the steps that the company is taking to correct its violations. S. Serra Cheese never responded to the FDA Warning Letter. Rather, the FDA’s requests went unanswered. Ignoring FDA warning letters often prompts the FDA to take action, which is often extremely costly and can cause delays, even halting business altogether. As Melinda K. Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs explains, “[w]hen a company ignores warnings or refuses to address food safety issues that put consumers at risk, the FDA must take action.”
You can read more about FDA warning letters and the importance of responding appropriately thereto, here. In order to resolve issues stemming from FDA warning letters, a company must provide the FDA with a detailed plan of action, describing specific things the company is doing to correct the violations. A company should include relevant documentation or other useful information that would assist the FDA in evaluating the thoroughness of the corrections. After submitting a plan to the FDA explaining these remedial steps, a company will sometimes receive another letter from the FDA with a determination of whether the FDA thinks the proposed steps will adequately resolve the problems at hand.
It is extremely important to respond to FDA warning letters both promptly and thoroughly. A FDA warning letter could result in penalties for your business, and in the case of S. Serra Cheese Company, the potential for personal liability. If you have any questions about FDA warning letters or compliance with FDA regulations, please contact us at firstname.lastname@example.org.