A federal court today entered a consent decree of permanent injunction prohibiting LGM Pharma LLC, a Florida company, from distributing active pharmaceutical ingredients not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).
According to court filings, LGM Pharma LLC is an importer and distributor of active pharmaceutical ingredients (APIs), which the company’s customers use to manufacture and compound finished drug products. In a complaint filed on Jan. 11, the United States alleged that LGM Pharma LLC, its chief executive officer, Prasad Raje, and its senior vice president of quality and regulatory affairs, Shailesh Vengurlekar, introduced into interstate commerce adulterated drugs that were manufactured, processed, packed, or held in conditions that do not comply with current good manufacturing practices (CGMP) as required under the FDCA. The complaint alleged that a 2022 FDA inspection of LGM’s Florida headquarters and a Kentucky facility where the company receives, holds, and distributes API identified significant departures from CGMP that posed a serious and ongoing risk to the public. The complaint further alleged that the problems observed in 2022 were similar to violations previously seen during a 2018 inspection of the Kentucky facility.
The defendants agreed to settle the suit and to be bound by a consent decree of permanent injunction. The consent decree, which resolves the case against all defendants, requires, among other things, that the defendants hire a CGMP expert to review and inspect LGM’s methods and controls used to receive, label, hold, and distribute drugs to determine whether the company’s processes and quality controls conform with CGMP. The consent decree also requires ongoing compliance auditing and reporting to FDA.
“Compliance by pharmaceutical importers and distributors with current good manufacturing practices is essential to ensuring the safety of drug products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to ensuring that companies importing and distributing drugs and active pharmaceutical ingredients comply with federal law.”
“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,” said Acting Director of the Office of Compliance Jill P. Furman, J.D. of the FDA’s Center for Drug Evaluation and Research. “LGM Pharma LLC’s failures to adhere to CGMP requirements put patients at risk. This consent decree requires the firm to implement and adhere to rigorous quality standards, under close FDA supervision. 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 drug products they rely on.”
The government was represented by Trial Attorneys Ann Entwistle and Rachael Doud of the Justice Department’s Consumer Protection Branch, with the assistance of Tracey Allen of the FDA’s Office of Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.
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