# FDA 483 - Sun Pharmaceutical Industries Limited - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-limited/79501485-3d89-4a81-a5e5-74e78330b880

> FDA 483 for Sun Pharmaceutical Industries Limited on February 07, 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: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Industries Limited in Mohali, India, revealed a significant issue with drug product testing. The firm failed to appropriately test batches of non-sterile drug products for objectionable microorganisms, specifically using unvalidated methods for method suitability tests. This indicates a serious lapse in quality control for products shipped to the United States market.

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- [483 - 2022-08-12](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-limited/586f3e16-ec32-4b99-9550-0213cbf2e92b)
- [483 - 2022-08-12](https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-limited/074bde2f-5ad2-42a9-805b-a497f54eaaaa)

## Related Officers

- [Philip F. Istafanos](https://www.globalkeysolutions.net/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/sun-pharmaceutical-industries-limited/286f1fa0-a9e6-4928-acc7-c3a4ef147b87

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