API Distributor LGM Pharma Enters Consent Decree
A federal court in Florida has issued a consent decree against LGM Pharma, a Boca Raton-based active pharmaceutical ingredient (API) importer and distributor, prohibiting the company from distributing APIs that don’t comply with current good manufacturing practices (cGMP).
The Department of Justice filed a complaint on the FDA’s behalf against LGM Pharma after the company’s Florida headquarters and Kentucky facility were found, during FDA inspections in 2022, to pose “a serious and ongoing risk to the public.”
The FDA observed inadequate investigations of quality-related customer complaints, failure to properly qualify foreign API manufacturers and inadequate procedures for distribution of drugs “after an API supplier has been disqualified by the company.”
The consent decree sets up a strict timetable for LGM Pharma to conform to cGMP requirements and requires the company to hire a cGMP expert to review the methods and controls used to receive, label, hold and distribute drugs.
The consent decree also requires the firm to undergo ongoing auditing and to report to the FDA. If the remedial steps are unsatisfactory, the FDA may take certain actions, including ordering the company to “cease receiving, labeling, holding and/or distributing any or all drug substances,” the agency said.
February 2, 2023
