FDA 483 - Bio-rad Laboratories, Inc. - March 07, 2023

An FDA inspection conducted at Trivedi Science, Inc., a repacker/relabeler and contract laboratory in Howe, IN, from January 22 to February 5, 2024, identified significant deficiencies in the firm's quality management systems. The primary concerns revolved around inadequate Out-of-Specification (OOS) investigations, a repeat observation. The Quality Control Unit failed to ensure OOS investigations for active pharmaceutical ingredients (APIs) were adequately supported by documented evidence, such as video reviews or analyst interviews, leading to the release of lots based on unsupported retest results.

Furthermore, the inspection revealed a lack of formal procedures for transferring and verifying customer-supplied analytical methods, with method qualification lacking predefined acceptance criteria. The firm also failed to thoroughly review unexplained discrepancies in OOS results and did not consistently follow its own procedures. Another critical issue was an inadequate cleaning validation program for non-dedicated equipment used to repackage various APIs, including potent and beta-lactam compounds. Specifically, the program lacked a dirty hold time study, which is essential for preventing cross-contamination.

These observations indicate non-compliance with several sections of 21 CFR Part 211, which governs Current Good Manufacturing Practice for Finished Pharmaceuticals. Trivedi Science, Inc. must implement robust corrective actions to address these systemic issues, ensuring all quality control processes, laboratory procedures, and equipment cleaning protocols meet regulatory standards and are fully documented to ensure product quality and patient safety.