# FDA 483 - Sun Pharmaceutical Industries Limited - January 20, 2020

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-limited/75890b37-2c1b-4c9d-9eed-2c7e291c25c7

> FDA 483 for Sun Pharmaceutical Industries Limited on January 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Limited
- Inspection Date: 2020-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Industries Limited, an API manufacturer in Ahmednagar, India, revealed deficiencies in the receiving controls for temperature-sensitive drug ingredients. The firm failed to provide adequate equipment and written procedures for temperature control, specifically by not verifying the temperature of incoming ingredients or data logger records from transporters. This indicates a lack of robust quality control over critical raw material receipt.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.globalkeysolutions.net/companies/sun-pharmaceutical-industries-limited/51c5d6b8-303e-4e32-bbef-eaca05e879ef

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