# FDA 483 - Sun Pharmaceutical Industries Limited- Madhuranthagam - February 17, 2023

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-limited-madhuranthagam/e472bee1-f895-4350-9a35-fc521fb744f9

> FDA 483 for Sun Pharmaceutical Industries Limited- Madhuranthagam on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Limited- Madhuranthagam
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Industries Limited- Madhuranthagam, an API manufacturer, revealed that laboratory testing was not performed under controlled conditions. Specifically, the firm failed to maintain required humidity control during the handling and testing of a highly hygroscopic API and lacked adequate procedures to minimize environmental exposure during multiple tests. This indicates a significant lapse in quality control for critical product testing.

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-limited-madhuranthagam/29c2adf0-d756-44f5-aefc-28f06be9616a

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