FDA 483 - Symbiotec Pharmalab Limited - September 30, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Symbiotec Pharmalab Pvt. Limited, an API manufacturer in Pithampur, India, revealed significant deficiencies across six observations. The firm failed to follow laboratory control procedures, adequately validate cleaning processes for non-dedicated equipment, and establish proper monitoring for processing steps. Additionally, the inspection found issues with the investigation of computerized system errors, the review of analytical method validation documents, and the timely resolution of quality complaints.
ID · 4e3aad04-a511-45b9-a863-c5458474221b