# FDA 483 - Pfizer Healthcare India Private Limited - October 18, 2022

Source: https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/d4990f8b-8170-4751-8910-2b4c040a6367

> FDA 483 for Pfizer Healthcare India Private Limited on October 18, 2022. 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: 2022-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pfizer Healthcare India Private Limited in Visakhapatnam, India, a sterile drug manufacturer, revealed significant deficiencies in equipment design, qualification, and maintenance. These issues led to particle contamination in drug products, resulting in multiple recalls and Field Alert Reports, and the presence of rust in manufacturing vessels. The firm failed to adequately qualify cleaning equipment and implement proper preventative maintenance actions.

## Related Documents

- [483 - 2019-09-02](https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/4dbc165b-d356-4c51-94d9-c86ffd9c3e34)
- [WARNING_LETTER - 2019-09-06](https://www.keypedia.com/records/warning_letter/pfizer-healthcare-india-private-limited/5f96070a-9d0d-4a20-a254-22cfb2546131)

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

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