# FDA 483 - Pfizer Healthcare India Private Limited - September 02, 2019

Source: https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/4dbc165b-d356-4c51-94d9-c86ffd9c3e34

> FDA 483 for Pfizer Healthcare India Private Limited on September 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Healthcare India Private Limited
- Inspection Date: 2019-09-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pfizer Healthcare India Private Limited in Visakhapatnam identified critical deficiencies in their sterile drug product manufacturing. The firm failed to thoroughly investigate sterility test failures and environmental monitoring excursions, indicating a lack of robust root cause analysis. Additionally, the quality unit did not adequately manage sterilization alarms or ensure proper biological quality laboratory operations, and disinfectant validation was found to be insufficient against prevalent microorganisms.

## Related Documents

- [WARNING_LETTER - 2019-09-06](https://www.keypedia.com/records/warning_letter/pfizer-healthcare-india-private-limited/5f96070a-9d0d-4a20-a254-22cfb2546131)
- [483 - 2022-10-18](https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/d4990f8b-8170-4751-8910-2b4c040a6367)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/pfizer-healthcare-india-private-limited/50c6f34f-3ef8-4cd6-bd55-6e1ee280d4f7

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