FDA 483 - Lex, Inc. - February 28, 2023

An FDA inspection conducted from February 13-28, 2023, at Lex Inc. DBA Lex Pharmaceutical, an OTC drug and dietary supplement manufacturer, revealed significant deviations from regulatory standards. The firm exhibited critical issues in material control, including accepting supplier analyses without validation, lacking a vendor qualification program, and failing to test raw materials to full specifications. Notably, essential components like Propylene Glycol, Glycerin, and Polyethylene Glycol were not tested for harmful impurities, such as Diethylene Glycol and Ethylene Glycol. Raw materials and finished products were frequently released without complete analytical testing. Systemic failures were also observed in manufacturing process controls. The company had not performed process validation for numerous OTC drug products, lacked qualification for production equipment, and had inadequate calibration procedures. The quality control unit demonstrated severe deficiencies, including an absent formal change control system and no established Corrective and Preventive Action (CAPA) program. Batch records were improperly handled, and stability protocols for OTC drugs were non-existent, compromising product quality assurance. Annual product reviews were incomplete and lacked proper management approval. For dietary supplements, similar quality control breakdowns included the release of out-of-specification components, a lack of established product specifications for finished botanical supplements, and the use of scientifically invalid test methods. Raw materials were released prematurely, and finished dietary supplements were distributed before quality control release. Components were also found unlabeled, posing a risk of mix-ups. Many of these deficiencies were repeat observations from previous inspections, indicating a persistent failure to adhere to Good Manufacturing Practices. Lex Pharmaceutical is required to promptly address these observations to ensure compliance with federal regulations governing drug and dietary supplement manufacturing.