District Court Enters Permanent Injunction Against Florida-Based Drug Importer And Distributor | OPA

A federal court today issued a permanent injunction prohibiting LGM Pharma LLC, a Florida company, from distributing active pharmaceutical ingredients that are not manufactured, processed, or stored in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA).

According to court documents, LGM Pharma LLC is an importer and distributor of active pharmaceutical ingredients (APIs), which the company’s customers use to manufacture and compound finished medicines. In a complaint filed on Jan. 11, the United States alleged that LGM Pharma LLC, its CEO, Prasad Raje, and its senior vice president of quality and regulatory affairs, Shailesh Vengurlekar, introduced into interstate commerce counterfeit drugs manufactured , processed, packaged or stored in conditions that do not comply with current good manufacturing practice (CGMP) as required under the FDCA. The complaint alleged that a 2022 FDA inspection of LGM’s Florida headquarters and a facility in Kentucky where the company receives, stores and distributes API identified significant deviations from CGMP that posed a serious and ongoing risk to the public. The complaint further alleged that the issues observed in 2022 were similar to violations previously observed during a 2018 inspection of the Kentucky facility.

The defendants agreed to settle the lawsuit and be bound by a consent decree of permanent injunction. The consent decree, which settles the case against all defendants, requires, among other things, that the defendants hire a CGMP expert to review the LGM methods and controls used to receive, label, hold and distribute drugs and inspect to determine if the company’s processes and quality controls are compliant with CGMP. The consent decree also requires ongoing compliance monitoring and reporting to the FDA.

Compliance by pharmaceutical importers and distributors with current good manufacturing practices is essential to ensuring drug safety, said Chief Deputy Assistant Attorney General Brian M. Boynton, chief of the Justice Department’s civil division. The department is committed to ensuring that companies that import and distribute drugs and active pharmaceutical ingredients comply with federal law.

Protecting patients means holding all parts of our drug supply chain to the highest quality standards permitted by law, including importers and distributors of both finished drugs and active pharmaceutical ingredients, said Jill P. Furman, acting director of the Office of Compliance, JD of the FDA’s Center for Drug Evaluation and Research. LGM Pharma LLC’s failure to adhere to CGMP requirements puts patients at risk. This authorization decree requires the company to implement and adhere to strict quality standards, under the close supervision of the FDA. We will continue to do everything in our power to ensure compliance and address violations of federal law to protect the American public and the safety of the medicines they rely on.

The government was represented by trial attorneys Ann Entwistle and Rachael Doud of the Department of Justice’s Division of Consumer Protection, with the assistance of Tracey Allen of the FDA’s Office of Chief Counsel.

Additional information about the Department of Consumer Protection and its enforcement efforts can be found at http://www.justice.gov/civil/consumer-protection-branch.

The claims resolved by the resolution announced today are mere allegations and there has been no determination of liability.