CGMP Violations at Lex, Inc.

A 2/13-2/28 FDA inspection at the Lex, Inc., drug manufacturing facility in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/17 Warning Letter says the violations were:

• failure of the quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
• failing to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit;
• failing to conduct at least one test to verify the identity of each component of a drug product;
• failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
• failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and the failure of the quality control unit to review and approve the written procedures, including any changes;
• failing to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product, and failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records.

The letter says significant inspection findings “demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective production operations oversight to ensure reliable facilities and equipment, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

FDA says that because the company failed to correct repeat violations from inspections in 2004, 2005, 2009, 2011, and 2016, the agency recommends that it engage a qualified consultant to assist it in meeting CGMP requirements. The agency reminds Lex that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with product owners.

Lex was told to promptly correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.