# FDA 483 - Sun Pharmaceutical Industries Ltd. - May 09, 2022

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/e578fe89-e979-4212-a934-706675c1e96e

> FDA 483 for Sun Pharmaceutical Industries Ltd. on May 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2022-05-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, received a Form 483 with 10 observations primarily concerning aseptic processing, environmental monitoring, equipment design and cleaning, laboratory controls, quality unit responsibilities, and personnel training. The observations highlight significant deficiencies in preventing microbiological contamination, ensuring product purity, and adequately investigating discrepancies and complaints. The firm also failed to conduct timely stability testing and ensure proper visual inspection of drug products.

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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

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