A federal court ordered Morton Grove Pharmaceuticals on Friday to stop “directly or indirectly manufacturing, processing, packing, labeling, holding, or distributing any drug” product citing GMP regulations. The company is restrained from the aforementioned activity until its GMP operations are in compliance with applicable laws and regulations and certified as such by an expert.
“Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply,” said Director Donald Ashley of the FDA’s Center for Drug Evaluation and Research, Office of Compliance. “These manufacturing fundamentals are necessary to ensure the public is not put at risk from adulterated drug products. Today is a culmination of the dogged oversight needed to hold drug manufacturers accountable for the safety, efficacy, and quality of the drug products they produce as we work to best protect public health.”
The company agreed to settle the suit and be bound by a consent decree permanently enjoining it from violating the Food, Drug and Cosmetic Act. The company is expected within 60 days of the court order to destroy all violative drugs in the company’s possession, and is responsible for destruction costs and costs associated with subsequent audits and inspections.
FDA alleged that it inspected the facility five times in a 10-year period from 2011 to 2021, emphasizing the importance of responding to agency-issued Warning Letters, which are often viewed by industry as having no teeth.