Federal court issues consent decree against Florida-based drug importer and distributor

Today, the US District Court for the Southern District of Florida entered a permanent injunction consent decree against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (APIs), used by the company’s customers. to manufacture and/or compound finished pharmaceutical products. , and two of the company’s executives, CEO and co-owner Prasad Raje and Shailesh Vengurlekar, the company’s senior vice president of quality and regulatory affairs.

The consent decree establishes a strict timeline and requirements for the company to ensure compliance with current Good Manufacturing Practice (CGMP) requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among other things, the consent decree requires ongoing compliance audits and reporting to the US Food and Drug Administration and also provides that the FDA may take appropriate action, including ordering the company to stop receiving , label, store and/or distribute any or all medications. substances, should defendants further violate the FD&C Act, its implementing regulations, or the consent decree.

According to the complaint filed by the US Department of Justice on behalf of the FDA, LGM Pharma LLC introduced into interstate commerce adulterated drugs that were manufactured, processed, packaged, or stored under conditions that did not meet FDA requirements. CGMP under the FD&C Act.

“Protecting patients means we must hold all parts of our drug supply chain to the highest quality standards allowed by law, including importers and distributors of both finished pharmaceutical products and active pharmaceutical ingredients,” said Jill P. Furman, JD, acting director of the FDA’s Office of Compliance, Center for Drug Evaluation and Research. “Failure to comply with CGMP requirements by LGM Pharma LLC puts patients at risk. This consent decree requires the company to implement and adhere to rigorous 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 pharmaceuticals they depend on.”

The agency inspected the company’s Florida and Kentucky facilities in 2022. During these inspections, FDA identified significant deviations from CGMP requirements, including the company’s failure to conduct adequate investigations of quality-related customer complaints involving Out-of-Specification (OOS) APIs it distributed, failure to properly qualify foreign manufacturers of APIs imported and distributed by the company, and failure to establish proper procedures for drug distribution after the company has disqualified a supplier of APIs. A previous inspection of LGM Pharma LLC’s Kentucky facility also revealed significant non-compliance with CGMP requirements, including the company’s inappropriate relabeling of APIs, a lack of sufficient qualification procedures for foreign API suppliers from the company and the lack of adequate investigations of the requirements related to quality. customer complaints involving OOS APIs distributed by the company.

Today’s action will require the company to take detailed quality-related compliance actions to ensure that the company’s processes for importing and distributing medicines comply with CGMP requirements and federal law.

The case was brought by the Consumer Protection Branch of the United States Department of Justice, on behalf of the FDA.

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