# FDA 483 - Sun Pharmaceutical Medicare Limited - February 27, 2024

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/6a1d3841-f2ae-4d88-8fee-4aac9873a462

> FDA 483 for Sun Pharmaceutical Medicare Limited on February 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Medicare Limited
- Inspection Date: 2024-02-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Medicare Ltd., a sterile drug manufacturer in Halol, Gujarat, India, revealed significant deficiencies in preventing microbiological contamination during the manufacturing of sterile drug products. The inspection also cited failures to thoroughly investigate out-of-specification results and atypical events, as well as the use of unqualified production equipment. These observations indicate serious concerns regarding the firm's quality control and manufacturing practices for sterile products.

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## Related Officers

- [Feiyan Jin](https://www.globalkeysolutions.net/people/feiyan-jin/a934b818-7fd6-4511-b9fd-5b9a9bb67225)
- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

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