A company that distributes ready-to-eat (RTE) tuna sandwiches has been enjoined from preparing and distributing its products until it complies with the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) as well as current good manufacturing practice (CGMP) requirements for food. The injunction follows FDA inspections that revealed the unsanitary conditions in which the food was prepared as well as a civil complaint filed by the Department of Justice (DOJ) (U.S. v. Scotty’s Inc., May 12, 2016, Cleland, R.).
Inspections and complaint. The FDA inspected Scotty’s, based in Detroit, and found that the company’s sandwiches were adulterated (see Michigan ready-to-eat tuna sandwiches could be toxic, DOJ warns, November 24, 2014). The DOJ’s complaint alleged that Scotty’s failed to create and implement a Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood, and it lacked control records documenting various safety measures. Although Scotty’s argued that it was not subject to HACCP regulations and that it had addressed the FDA’s safety concerns, the district court was not convinced of the company’s ability to comply with regulations and granted the injunction (see Company’s tuna salad processing smells fishy to FDA, injunction granted, March 30, 2016).
Injunction. The government was required to supply the form of injunction it desired by April 1, 2016. The court ultimately entered an order of permanent injunction against Scotty’s, preventing the company from distributing its sandwiches from any locations until the company retains an independent expert to assist it in complying with the FDC act and CGMP. The company must develop and implement a written sanitation control program, comply with HACCP regulations, and develop employee training programs. The expert must inspect Scotty’s facility and establish procedures to ensure that all controls are administered properly.
The company must seek FDA approval of its plans and programs. Under FDA supervision, Scotty’s must destroy all RTE sandwiches and ingredients in the company’s possession at the time of the order. The company must bear the FDA’s costs of inspection and oversight. The company may not resume operations until the FDA notifies it in writing that it is in compliance with all of the requirements.
The case is 2:14-cv-14450-RHC-RSW.
Attorneys: Ann Entwistle, U.S. Department of Justice, for the United States of America. Jerome A. Moore (Jerome A. Moore, Attorney at Law) for Scotty's Inc.
Companies: United States of America; Scotty's Inc.
MainStory: TopStory CaseDecisions FDCActNews AdulterationNews InspectionNews FoodSafetyNews FoodStandardsNews MichiganNews
Interested in submitting an article?
Submit your information to us today!Learn More
Health Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.