# FDA 483 - Megafine Pharma (P) Limited - May 08, 2023

Source: https://www.globalkeysolutions.net/records/483/megafine-pharma-p-limited/6ca92725-e717-40fe-a512-f3deb67e14eb

> FDA 483 for Megafine Pharma (P) Limited on May 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Megafine Pharma (P) Limited
- Inspection Date: 2023-05-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Macafine Pharma (P) Ltd, an Active Pharmaceutical Ingredient manufacturer in Vapi, Gujarat, revealed significant deficiencies in laboratory controls and quality system processes. The firm failed to adequately test water used in API intermediate manufacturing for microbial content and TOC, and did not properly identify microbial colonies during water system validation. Additionally, the inspection found that investigations into deviations and failures were not timely, lacked proper justification for extensions, and were not consistently expanded to include other potentially affected batches or components, with many CAPAs remaining open for extended periods.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/megafine-pharma-p-limited/47f3a083-30b0-4f15-ac09-3f99d5e75442

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