# FDA 483 - Pfizer Asia Manufacturing Pte Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/pfizer-asia-manufacturing-pte-ltd/ad071b5b-5e9f-4973-b5fe-8ab6d12553b1

> FDA 483 for Pfizer Asia Manufacturing Pte Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Asia Manufacturing Pte Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/pfizer-asia-manufacturing-pte-ltd/77c4ecfd-af67-404b-8091-9c254525198b

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1