Violation of FDA Regulations Prompts Seizure by U.S. Marshals
On August 25, 2011, U.S. Marshals seized various seafood products from a manufacturing facility in California. Prompting the seizure, the U.S. Food and Drug Administration (FDA) requested the marshals take action against Meiko Food Co. after finding the companys operations were not compliant with the federal Food, Drug, and Cosmetic Act (FDCA) and accompanying FDA regulations.
As discussed here, the FDA sought action against the seafood manufacturer because of continued non-compliance, despite repeated FDA warnings. In particular, the FDA found that Meikos seafood products were adulterated because the company failed to have a Hazard Analysis Critical Control Point (HACCP) plan in place. A HACCP plan is one of many preventative controls that the FDA requires manufacturers to have in place in order to ensure health risks are being monitored and reduce food borne illness outbreaks.
As found in an FDA Warning Letter to Meiko late last year, the FDA had previously cited the company for its failure to have a HACCP plan. Thus, the seafood manufacturers continued failure to address FDAs warnings led the Agency to step up its enforcement actions against the company. Had the seafood manufacturer taken the necessary steps called for by the warning letter, it may have avoided further FDA action.
Because the FDA typically issues warning letters before taking any serious action against non-compliant parties, it is important to take warning letters seriously and take any necessary corrective measures in order to avoid further enforcement action.
For more information on FDA enforcement measures or other compliance issues, please contact us at contact@fidjlaw.com.