# FDA 483 - Global Pharma Healthcare Private Limited - March 02, 2023

Source: https://www.globalkeysolutions.net/records/483/global-pharma-healthcare-private-limited/f05df7af-2618-483c-9c4d-a1e8e943af0c

> FDA 483 for Global Pharma Healthcare Private Limited on March 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Pharma Healthcare Private Limited
- Inspection Date: 2023-03-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Global Pharma Healthcare Pvt. Ltd. in Thiruporur, India, revealed significant deficiencies in the manufacturing of sterile drug products. The firm lacked adequate validation for sterilization processes, environmental controls, and equipment, compromising the sterility assurance of products distributed to the U.S. market. Multiple observations highlighted failures in quality control, testing, and adherence to written procedures.

## Related Documents

- [WARNING_LETTER - 2023-03-02](https://www.globalkeysolutions.net/records/warning_letter/global-pharma-healthcare-private-limited/79513895-3d08-4ae6-9113-05ac331e8ed6)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.globalkeysolutions.net/companies/global-pharma-healthcare-private-limited/8f187dbf-2b20-4c37-b41d-c8c03a963bdb

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