LGM Pharma Faces Permanent Injunction for FD&C Act Violations

The US District Court for the Southern District of Florida has entered a consent decree of permanent injunction against LGM Pharma LLC, according to the Food & Drug Administration Monday.

The consent decree requires the company to meet current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetics Act. LGM Pharma must also maintain ongoing compliance auditing and reporting to the US Food and Drug Administration, FDA said.

The company allegedly introduced adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements into interstate commerce, said the agency.

This story ...