# FDA 483 - Sun Pharmaceutical Medicare Limited - July 13, 2023

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/a78c96ec-097e-4866-95cf-cdd0be0da582

> FDA 483 for Sun Pharmaceutical Medicare Limited on July 13, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Medicare Limited
- Inspection Date: 2023-07-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Medicare Limited, a sterile drug manufacturer in Halol, India, revealed significant deficiencies in their quality control laboratory. The firm failed to adequately investigate numerous "Unsuccessful Logon Attempt" messages in their Empower software audit trail, which is used for drug product testing. This lack of investigation raises concerns about data integrity and unauthorized access to analytical raw data.

## Related Documents

- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/2f3cb4ef-1734-4b47-ad18-4f3dbc4ea63b)
- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/9f8de95a-40c8-475d-ac17-75f6b3f155fe)
- [483 - 2024-02-27](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/6a1d3841-f2ae-4d88-8fee-4aac9873a462)
- [483 - 2025-09-19](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/5fc49daf-8bcf-4402-83a4-db9144a7c716)
- [483 - 2025-09-19](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/a7dff9c0-ed8d-4c8c-aaa5-ccaf9dcdd0a0)

## Related Officers

- [Regulatory Affairs Specialist](https://www.globalkeysolutions.net/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/sun-pharmaceutical-medicare-limited/bcde6f4d-9644-445c-b813-cb49ed881f97

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