By

FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

FDA , , ,
On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and Critical Control Points (HACCP) food safety management system, which according to FDA must be followed under federal law. Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the…
Read More
By

FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

FDA , , , , , ,
On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, juice, and vegetable manufacturing company located in Puerto Rico.  Under the consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico, the Company agrees to cease all operations until it complies with the Federal Food, Drug, and Cosmetic Act (“FDCA”). This will include complying with Current Good Manufacturing Practice (“cGMP”) and Hazard…
Read More