FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - October 17, 2024
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 Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, revealed a critical failure to thoroughly review unexplained discrepancies during drug substance manufacturing. Specifically, the firm did not properly investigate or document critical alarms related to pressure readings and flow rates for BEQVEZ (FidaVec) drug substance batches. Several affected batches were subsequently released by QA without a proper impact assessment, indicating a significant lapse in quality control.
- Inspection Date
- October 17, 2024
- Product Type
- Biologics
ID · 47e17b26-1ded-497c-b42f-74e591b7455a