Aldrich Chemical – FDA 483, Dec 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.