483
Sigma-Aldrich Manufacturing LLCSigma-Aldrich Manufacturing LLC – FDA 483, Apr 28, 2025
Record Details
An FDA inspection of Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, a human drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate manufacturing deviations, including repeat observations, and lacked appropriate specifications and risk assessments for nonsterile APIs. Additionally, computerized systems allowed unauthorized data alteration, and process validation activities were found to be scientifically inadequate.
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ID · 21ff8057-badb-41ca-918d-7e4a2779a619
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