# FDA 483 - Sun Pharmaceuticals Industries Ltd. - March 29, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceuticals-industries-ltd/1e997e45-efaa-4768-9fe2-1b15c882e52b

> FDA 483 for Sun Pharmaceuticals Industries Ltd. on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sun Pharmaceuticals Industries Ltd.
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sun Pharmaceutical Industries Limited in Dadra, India, revealed significant deficiencies across its quality, production, and facilities systems. The firm was cited for inadequate employee training, lack of proper production and process controls, insufficient investigation of errors, and poor equipment cleaning. These issues indicate a systemic failure to ensure drug product quality and compliance with Good Manufacturing Practices.

## Related Documents

- [483 - 2017-04-13](https://www.keypedia.com/records/483/sun-pharmaceuticals-industries-ltd/f8cc4a5f-70b7-4456-8bec-532981460909)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/sun-pharmaceuticals-industries-ltd/fe206618-23a6-40bd-8574-5d19b2946ca3)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/sun-pharmaceuticals-industries-ltd/9d0d50d4-c388-4ecf-bab6-ed69e20170da)

## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)
- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)

Company: https://www.keypedia.com/companies/sun-pharmaceuticals-industries-ltd/758af0ba-71ed-4144-b6c7-e175eaafa473

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