# Pfizer Healthcare India Private Limited – FDA 483

Source: https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/e45ea7f9-20fb-44a2-a86d-3286a7d8a034

> FDA 483 for Pfizer Healthcare India Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Healthcare India Private Limited
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Hospira Healthcare India Pvt. Ltd. in Visakhapatnam, India, a sterile drug manufacturer, revealed severe deficiencies in microbiological contamination prevention, environmental monitoring, and data integrity. The report highlighted repeated findings of Gram negative and Gram positive organisms, inadequate investigations, and a lack of control over critical manufacturing processes and data. Many of these issues were repeat observations from a previous inspection, indicating persistent quality system failures.

## Related Documents

- [483 - 2022-10-18](https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/d4990f8b-8170-4751-8910-2b4c040a6367) — date: October 18, 2022
- [WARNING_LETTER - 2019-09-06](https://www.keypedia.com/records/warning_letter/pfizer-healthcare-india-private-limited/5f96070a-9d0d-4a20-a254-22cfb2546131) — date: September 6, 2019
- [483 - 2019-09-02](https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/4dbc165b-d356-4c51-94d9-c86ffd9c3e34) — date: September 2, 2019
- [483 - 2018-09-21](https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/3c3051ca-5bac-49f1-bd87-de0e740dc4f4) — date: September 21, 2018

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [issuing_officer](https://www.keypedia.com/people/toyin-b-oladimeji/0aff4ab4-a1ff-4394-a32d-747bdc5f248b)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4