FDA 483 - Lexia LLC - September 29, 2025

During an inspection from September 23-29, 2025, the FDA issued a Form 483 to Lexia LLC, identifying significant deviations from Current Good Manufacturing Practices (CGMP) in the manufacturing of its OTC LF Cream. Key observations highlighted a complete absence of a quality control unit responsible for approving or rejecting materials and products. Lexia LLC lacked fundamental written procedures for critical quality processes, including complaint handling, adverse event reporting, corrective and preventive actions (CAPA), deviation management, change control, recall procedures, and personnel training. Furthermore, the inspection revealed deficiencies in microbiological control, with no established procedures to prevent contamination, and no testing for objectionable microorganisms in the product or the water system used in manufacturing. Equipment cleaning programs were also unvalidated. The firm also lacked a written program to assess drug product stability, meaning expiration dates were unsupported, and failed to conduct adequate final product testing for release. Other critical issues included inadequate control over components, containers, and closures, such as accepting supplier certificates of analysis without in-house testing and the use of expired raw materials. Labeling and packaging controls were also insufficient, with no detailed specifications or proper examination of incoming materials. Finally, batch production records were incomplete, lacking essential documentation of manufacturing steps, equipment usage, material identification, and quality control results. Lexia LLC is required to address these observations by implementing a comprehensive quality system, establishing and following robust written procedures for all manufacturing and quality control activities, validating processes, and ensuring proper documentation to comply with CGMP regulations.