# FDA 483 - Sun Pharmaceutical Industries Ltd. - June 11, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/9a238e21-583d-4f1d-9584-916caa09a278

> FDA 483 for Sun Pharmaceutical Industries Ltd. on June 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2019-06-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 details significant deficiencies at Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, observed during a June 2019 inspection. The firm failed to follow procedures for sterile drug product manufacturing, maintain proper laboratory control documentation, adequately establish design plans for a medical device, and validate a critical assembly process. These issues indicate a lack of robust quality control and process validation.

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## Related Officers

- [Rebecca E. Dombrowski](https://www.keypedia.com/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
- [other](https://www.keypedia.com/people/kejun-cheng/cc135464-ed6c-4c5d-8a25-9f40ed8e2cc6)
- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)
- [Food and Nutration Service ](https://www.keypedia.com/people/farhana-khan/2388f1b3-b96c-4ae9-a520-d469ef762ce9)

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