The U.S. District Court for the Southern District of Florida has entered into a consent decree with the Florida-based company LGM Pharma LLC and two executives of the company, CEO Prasad Raje and Senior Vice President of Quality and Regulatory Affairs, Shailesh Vengurlekar. According to a Jan. 30 announcement by the FDA, LGM, an importer and distributor of active pharmaceutical ingredients, is now under permanent injunction.

Active pharmaceutical ingredient importers such as LGM transport materials into the U.S. where they are used to manufacture or compound drugs. According to the complaint filed by the U.S. Department of Justice (DOJ) on behalf of the FDA, LGM Pharma LLC distributed “adulterated drugs” that were in violation of the current good manufacturing practice (GMP) requirements of the Food Drug & Cosmetics Act.

The FDA inspected LGM Pharma’s facilities in Florida and Kentucky in 2022. The agency found “significant departures” from current GMP requirements, including failure-to-perform investigations of quality-related customers’ complaints of active pharmaceutical ingredients that were out-of-specification, distributing altered active pharmaceutical ingredients, and failure to establish procedures for drugs with active pharmaceutical ingredients supplied by a non-compliant supplier.

The findings of this investigation, combined with a previous inspection of LGM Pharma’s Kentucky facility that returned similar results as well as improper relabeling of active ingredients, led to the decision to ask the DOJ to step in. Under the new consent decree, a strict timetable is established by which LGM Pharma must enter into compliance with current GMP requirements. The consent decree enforces this timetable through ongoing compliance audits and reports submitted to the FDA. Failure to comply will result in the FDA ceasing LGM Pharma’s ability to receive, label, hold, or distribute “any or all drug substances.”

Acting director of the FDA’s Office of Compliance in the agency’s Center for Drug Evaluation and Research, Jill P. Furman, J.D. stated,  “Protecting patients means we must hold all parts of our drug supply chain to the highest standards of quality allowed by law, including importers and distributors of both finished drug products and active pharmaceutical ingredients.” 

Furman added that LGM Pharma’s failure to keep to current GMP requirements has placed the safety of patients at risk.