At the request of the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ) today filed a complaint for permanent injunction against Brooklyn-based juice company, Juices Incorporated (also known as Juices International and Juices Enterprises), to prevent it from processing and distributing juice products.
Juices Incorporated and its owners are charged with violating the Federal Food, Drug, and Cosmetic Act for failing to comply with Hazard Analysis and Critical Control Point (HACCP) and Good Manufacturing Practices (GMP) policies.
This action comes as a result of the FDA’s most recent inspection of the Juices facility in March 2010, during which the agency found the same or similar violations observed during earlier inspections. The agency previously issued warning letters to the company in April 2008 and October 2009, to which the company reportedly submitted responses promising to bring its operations into compliance but did not make the necessary changes. The company’s failure to correct violations prompted FDA to seek court action.
FDA’s Associate Commissioner for Regulatory Affairs Dara A. Corrigan said, “Today’s action shows that FDA will seek enforcement action to make sure that those companies that must have preventative controls in place to ensure the safety of their products adhere to all applicable requirements.”
This action serves as a warning to companies that have taken FDA warning letters lightly over the past years, seeing them as nothing more than an initial notice. For most companies the time to start addressing deviations is immediately following an FDA inspection, when presented with the 483 inspection findings. With an understanding of violations cited on the 483, an FDA attorney may be able to negotiate the with the FDA, prepare the company for the issuance and release of a Warning Letter, and implement business practices to prevent further deviations.
For more information on how our law firm can help your company prepare for an FDA inspection, respond to FDA-483 items, and respond to Warning Letters to avoid further administrative or enforcement action, contact Ann Marie Gaitan today. Mrs. Gaitan may be reached via e-mail at email@example.com or via telephone at 305.329.1462.