FDA 483 - Pfizer Asia Manufacturing Pte Ltd.

This FDA Form 483 was issued to Pfizer Asia Pacific Pte Ltd. in Singapore, an API manufacturer, following an inspection from March 11-15, 2019. The report details significant deficiencies in laboratory investigations, data review procedures, quality control processes, cleaning validation, document control, and batch record completeness. These observations indicate a lack of robust quality systems for ensuring product quality and data integrity.