FDA 483 - Bimeda MTC Animal Health Inc. - September 22, 2023

Bimeda MTC Animal Health Inc., a veterinary drug manufacturer, underwent an FDA inspection from September 14-22, 2023. The inspection revealed significant concerns regarding the firm's quality control and equipment management, documented in an FDA Form 483. A primary observation highlighted the company's failure to thoroughly investigate unexplained discrepancies and batch failures. For instance, investigations into excessive particle counts during drug product filling were deemed insufficient, lacking critical testing to determine particle source or nature. Similarly, unlisted interventions and equipment issues during production, such as repeated equipment jams, were not adequately investigated with sufficient data to assure batch quality. Further issues concerned instrument calibration and maintenance. The company failed to perform essential Performance Qualifications for its High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) systems. Additionally, monitoring and replacement schedules for UV lamps on HPLC systems were not followed, nor were daily checks or wavelength accuracy procedures for UV-Vis spectrophotometers. A lack of comprehensive maintenance records for system failures and uninvestigated root causes for system suitability issues across various analytical instruments also presented a critical gap in quality assurance. These observations indicate a need for the company to implement robust corrective actions to ensure compliance with good manufacturing practices and uphold product quality and safety.