483
Pfizer Asia Manufacturing Pte Ltd.FDA 483 - Pfizer Asia Manufacturing Pte Ltd.
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Record Details
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.
- Product Type
- Drugs
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ID · ad071b5b-5e9f-4973-b5fe-8ab6d12553b1