Morton Grove Pharmaceuticals Sued Over Alleged FDCA Violations

The United States of America filed suit on Wednesday in the Northern District of Illinois Eastern Division against defendants Morton Grove Pharmaceuticals, Inc. (MGP) and Gopalakrishnan Venkatesan. The complaint for permanent injunction alleges that the defendants’ drugs have been produced and marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Defendant MGP “manufactures non-sterile prescription and over-the-counter finished drug products in the form of oral, topical, and nasal solutions, suspensions, and powders and distributes them to pharmaceutical wholesale distributors and large pharmacy chains.” Defendant Venkatesan is the president at MGP.

Drug manufacturers like MGP are required by the Federal Food, Drug, and Cosmetic Act (FDCA) to comply with the CGMP (current good manufacturing practice) for drugs. Specifically, the defendants must “control the processes and procedures by which the drugs are manufactured, processed, packed, and held in order to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use.” If the defendants’ products are not made according to these guidelines, the products are considered adulterated under law.

Five separate FDA inspections determined that MGP’s drugs were adulterated since they were not in compliance with the CGMP. Some of the discrepancies uncovered by the FDA in their inspections included failures to reject and inspect drug lots that were potentially contaminated, failures to establish proper laboratory controls and sterilized environments, and more.

Defendant MGP represented in a June 2021 letter to the FDA that they were taking steps to correct their violations of the CGMP. However, the FDA ultimately concluded that “many of the firm’s proposed corrective actions [were] not adequate to fully address the CGMP violations that the FDA investigators observed during their inspection.” In their response, the FDA also referenced the defendants’ demonstrated history of noncompliance with the CGMP despite repeated warnings.

In the complaint, the plaintiff asserts their belief that the defendants will continue to violate the FDCA absent action from the Court. The plaintiff is seeking an injunction preventing further violations, preventing the sale of adulterated drugs, authorizing an FDA inspection of all business and records, and more.