# Pfizer Healthcare India Private Limited – FDA 483, Sep 21, 2018

Source: https://www.keypedia.com/records/483/pfizer-healthcare-india-private-limited/3c3051ca-5bac-49f1-bd87-de0e740dc4f4

> FDA 483 for Pfizer Healthcare India Private Limited on September 21, 2018. 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: 2018-09-21
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Pfizer Healthcare India Private Limited revealed serious data integrity issues within its microbiology laboratory, including supervisors instructing analysts to intentionally falsify growth promotion test results and environmental monitoring data. The firm also failed to submit Field Alert Reports in a timely manner and lacked adequate controls over computer systems to prevent unauthorized deletion of critical data. These findings indicate a systemic breakdown in quality control and data reliability.

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

## Related Officers

- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c