# FDA 483 - Sun Pharmaceutical Industries Ltd. - June 13, 2025

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/ed5722a3-9198-44c6-aa1e-d6c2e58376b9

> FDA 483 for Sun Pharmaceutical Industries Ltd. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, revealed critical deficiencies in aseptic processing and quality control, many of which were repeat observations from a previous Warning Letter. The firm failed to prevent microbiological contamination of sterile drug products, adequately validate aseptic processes, and thoroughly investigate discrepancies. These issues led to potential product quality concerns, including metal particulate contamination and the distribution of failing batches.

## Related Documents

- [483 - 2025-06-13](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/78be3f43-0bce-40cf-9d32-6f8000c36331)
- [483 - 2018-02-23](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/900452c3-8d0b-4801-bfb0-6232d5da6e83)
- [483 - 2018-08-31](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/abb59bb7-597b-42c5-9ae3-f69941eb7b87)
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- [483 - 2019-06-11](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/46808012-a2fb-45f6-8b29-9e553207cad7)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-ltd/0ee9565e-1ff7-4ffa-b6ad-c38bccdc32e6

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8