Pharmaceutical Manufacturer
LGM Pharma LLCInformation and Alerts
Alert Details
This business has 1 alert.
Government Actions
United States of America v. LGM Pharma LLC et al. Case number 9:23-cv-80040 S.D. Fla.
As of January 31, 2023:
A federal court 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.
LINK: https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-florida-based-drug-importer-and
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