A federal court ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
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In a civil complaint filed on August 17, the United States alleged that Morton Grove Pharmaceuticals Inc., violated the FDCA at the company’s facility in Morton Grove, Illinois, by manufacturing and distributing adulterated drugs.
Morton Grove Pharmaceuticals makes and distributes prescription and over-the-counter drugs, such as cough syrups and nasal sprays.
The Department of Justice alleged that the company violated the FDCA by failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination.
The department also alleged the Food and Drug Administration (FDA) inspected the company’s facility five times, in 2011, 2014, 2016, 2019, and 2021, and that many of the violations were repeat violations the FDA had identified in earlier inspections.
The current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which drugs are manufactured, processed, packed, and held, to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use.
Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law.
According to the Justice Department’s complaint, the FDA issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding alleged deficiencies at its facility.
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction.
The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing adulterated drugs.
Further, the defendants must destroy all drugs in the facility, except for those that are medically necessary. ■