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# Consent Decree Against LGM Pharma
- URL: https://www.fdaweb.com/consent-decree-against-lgm-pharma/
- Published: 2023-01-30T12:00:00.000Z
- Updated: 2026-09-14T18:13:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153653

The U.S. District Court for Southern Florida 1/20 entered a consent decree of permanent injunction against LGM Pharma and two of the company's executives, CEO **Prasad Raje** and quality and regulatory affairs senior vice president **Shailesh Vengurlekar**, to bring the company into CGMP compliance. LGM introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements under the FD&C Act., FDA [says](https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-florida-based-drug-importer-and-distributor?ref=fdaweb.com).

The agency’s 1/11 [complaint](http://www.fdaweb.com/download.php?file=boca%5F2023.pdf) says LGM imports and distributes drugs, including active pharmaceutical ingredients, from a facility in Erlanger, KY. FDA inspected the headquarters and Kentucky facilities in 3/2022 and 4/2022, it says, and found multiple instances in which the defendants failed to adhere to current good manufacturing practice regulations for receiving, holding, and distributing drugs. The agency says many of the violations seen in the 2022 inspection were similar to inspection observations in a 2018 inspection.

The consent decree requires ongoing compliance auditing and reporting to FDA, and also allows the agency to take appropriate action, including ordering the company to cease receiving, labeling, holding and/or distributing any or all drug substances, if the defendants further violate the FD&C Act or the consent decree.