FDA 483 - Precision Equine, LLC - September 22, 2023

During an inspection conducted from August 23 to September 22, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Precision Equine, LLC, a producer of sterile and non-sterile drug products located in Bakersfield, CA. This report details significant observations indicating a lack of adherence to manufacturing regulations, as outlined in the Federal Food, Drug, and Cosmetic Act.Key issues highlighted include inadequate procedures to prevent microbiological contamination in sterile drug products. Specifically, the company failed to perform frequent environmental and personnel monitoring, did not properly sanitize materials entering sterile environments, and exhibited poor aseptic technique. Facility design also had deficiencies, and hold times for depyrogenated supplies were not validated. The inspection further identified an absence of a comprehensive stability testing program, leading to extended product shelf-lives without sterility assurance. Potency testing was not routinely conducted for most finished drug batches before release, and both sterile and non-sterile finished products lacked essential microbiological testing. Equipment was found to be unclean with various stains and residues. The company failed to conduct identity testing for bulk drug substances or adequately validate supplier certificates of analysis for critical components. Additionally, investigations into unexplained discrepancies were not documented, and the quality control unit used ungraded ingredients. Precision Equine, LLC is required to address these serious observations with prompt corrective actions to ensure product quality and safety.