FDA 483 - Aldrich Chemical Co. LLC - June 20, 2016

Aldrich Chemical Co. LLC, an API manufacturer in Miami Township, Ohio, was cited for significant data integrity deficiencies during an FDA inspection. The firm failed to establish adequate controls to prevent the alteration or deletion of electronic raw data from an analytical instrument used for residual solvent analysis. This included issues with employee access, unauthorized computer access, and a lack of written procedures for data control and backup.