# FDA 483 - Sun Pharmaceutical Medicare Limited - February 05, 2019

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-medicare-limited/9f8de95a-40c8-475d-ac17-75f6b3f155fe

> FDA 483 for Sun Pharmaceutical Medicare Limited on February 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Medicare Limited
- Inspection Date: 2019-02-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Medicare Limited in Halol, Gujarat, a pharmaceutical manufacturer, revealed a significant issue regarding the firm's failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. The firm repeatedly invalidated OOS re-dispersibility test results by attributing them to human error during sample preparation without adequate supporting evidence. This indicates a serious lapse in quality control and investigation procedures.

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## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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