FDA 483 - Sigma-Aldrich Manufacturing LLC - February 06, 2019

Sigma Aldrich Manufacturing, LLC in Saint Louis, MO, an API manufacturer, was cited for significant quality system deficiencies. Observations included failures in investigating out-of-specification results and critical deviations, including falsified batch records and delayed customer reporting. Additionally, the firm failed to adequately investigate product complaints related to incompatible containers and lacked timely complaint investigation procedures.