GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

A federal court in the United States has entered a consent decree of permanent injunction against a Florida-based company. It prohibits the firm from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

The company in question, LGM Pharma LLC, is an importer and distributor of APIs, which the company’s customers use to manufacture and compound finished drug products. The FDA inspected the company’s facilities. During these inspections, several violations of current good manufacturing practices (CGMP) came out. These included:

• Failure to perform adequate investigations of quality-related customer complaints;
• Lack of sufficient qualification procedures for the company’s foreign API suppliers;
• Failures to establish adequate procedures for the distribution of drugs after an API supplier has been disqualified by the company.

The consent decree includes the following steps, among others:

• The company must hire a CGMP expert to make sure that the company’s processes and quality controls conform with CGMP;
• Ongoing compliance auditing and reporting to FDA;
• The FDA may take appropriate action if the company further violates the FD&C Act.

The legal dispute is thus considered to be settled.

Sources and further information:

• FDA, Press Announcement from 30 January 2023 - Federal Court Enters Consent Decree Against Florida-based Drug Importer and Distributor
• Department of Justice, press release number 23-114 from 30 January 2023 - District Court Enters Permanent Injunction Against Florida-Based Drug Importer and Distributor