FDA 483 - Pfizer Asia Manufacturing Pte Ltd. - October 27, 2021

Pfizer Asia Manufacturing Pte Ltd. in Singapore, an API manufacturer, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in contamination prevention within the dispensing room and significant issues with the quality control unit's procedures. These issues included incomplete investigations, inadequate water system monitoring, and a lack of proper controls and reconciliation for electronic batch records and raw data, indicating a gap in their data integrity system.