Morton Grove Pharmaceuticals is accused of drug cross-contamination.
A United States federal court has ordered Illinois-based Morton Grove Pharmaceuticals Inc., a large pharmaceutical company, to stop manufacturing and distributing its drugs. The drugmaker is a subsidiary of the Mumbai-based Wockhardt. The Department of Justice (DOJ) alleges the drugs produced by the company are in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). A civil complaint filed earlier this month suggests that the facility had been manufacturing and distributing adulterated drugs. Adulterated pharmaceuticals are those that have been altered in such a way as to reduce the quality or strength of the substance. Current practice regulations laid out by the FDCA mandate that manufacturers control the processes and procedures by which medications are produced, handled, and packaged in order to ensure their integrity and safety. The company failed to do so, according to court documents, resulting in possible cross-contamination which could be dangerous to consumers.
DOJ officials are also alleging the company had been inspected by the Federal Drug Administration (FDA) multiple times since 2011. Many of these inspections were made because the company repeatedly violated FDA standards and it needed additional oversight. Workhardt had once recalled several of its generic drugs in fear of the FDA banning sites in India because of quality concerns in 2015. This occurred after already having to shut down two of the drugmaker’s plants in Central India in 2013 due to what the department called “lapses in quality.” These lapses involved multiple violations of oversight standards including lack of controls, improper sterilization, in addition to other failures in quality control.
The specific quality concerns at the center of the current case involve the alleged contamination between cough syrup and nasal spray. The exact cause of the issue is not stated nor is the exact problems that could arise as a result. The FDA says, in general, “Any drug which is not recognized in an official compendium is adulterated if its strength differs from, or its purity or quality falls below that which it purports or is represented to possess, when tested by scientifically sound methods.”
“Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply. 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,” said Donald Ashley, director of the FDA’s Center for Drug Evaluation and Research, Office of Compliance.
Morton Grove Pharmaceuticals has taken heed of the DOJ’s federal court order and it has discontinued operations upon entering a consent decree with the agency. As part of the deal, the company agreed to close doors and sell the Illinois site. It also shared plans to permanently lay off 66 plant workers as production and processing of their generic prescription and over-the-counter drugs come to a halt. Wockhardt’s VP of Business Development, Gopalakrishnan Venkatesan, is also named as a defendant in the DOJ’s complaint.
District Court Enjoins Illinois Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs
U.S. Food and Drug Administration Inspections
Judge orders Morton Grove drug company to halt manufacturing
Federal Injunction Forces Pharmaceutical Manufacturer to Close Doors
FDA warning letter lays out issues at banned Wockhardt plants
CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act.
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