Aldrich Chemical – FDA EIR, Dec 13, 2021

An FDA surveillance inspection of Aldrich Chemical Co. LLC in Miamisburg, OH, conducted from December 6-13, 2021, identified several critical observations related to Active Pharmaceutical Ingredient (API) manufacturing. The inspection, performed under CPGM 7356.002F for API Process Inspections, resulted in a five-item FDA Form 483. Key issues included significant deficiencies in laboratory operations. The company failed to conduct thorough and timely investigations into discrepancies, frequently invalidating Out-of-Specification (OOS) results without comprehensive manufacturing investigations or scientific justification. Data integrity was compromised, as only paper data packets were reviewed, neglecting original electronic data and audit trails, and administrator rights for computerized systems were held by personnel with direct involvement in testing. Furthermore, essential equipment use logs for HPLCs and GCs were absent. Environmental monitoring practices were also found inadequate, with surface sample sites in GMP production areas not appropriately selected to represent actual activities. Lastly, employees were observed not adhering to proper gowning procedures, specifically regarding mask usage, violating internal safety protocols. Management acknowledged these findings and committed to providing a written response within 15 business days, pledging to implement necessary corrective actions.