483
Evonik CorporationFDA 483 - Evonik Corporation - August 10, 2018
Record Details
An FDA inspection of Everslik Corporation Birmingham Laboratories, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate computer system controls, unjustified deviations from validated production processes, and insufficient laboratory testing procedures for drug implants. Additionally, the inspection found a lack of quality oversight in their equipment preventative maintenance program.
Open in Dashboard
ID · 2f9545f6-3879-4608-a2ad-ab93cb990eec