FDA 483 - Aldrich Chemical - December 13, 2021

Aldrich Chemical Co, LLC, an API manufacturer in Miamisburg, OH, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate investigations into out-of-specification results and deviations, along with serious data integrity issues related to computerized systems and raw data review. Additional concerns included a lack of equipment use logs, insufficient environmental monitoring in GMP production areas, and improper employee gowning.