# FDA 483 - Sun Pharmaceutical Industries Ltd. - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-ltd/a825efb7-9662-4b1f-a2ee-debd514ac897

> FDA 483 for Sun Pharmaceutical Industries Ltd. on December 13, 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: 2019-12-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sun Pharmaceutical Industries Ltd. in Halol, India, a sterile and non-sterile drug manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations highlight systemic failures in quality control, data integrity, aseptic processing, and manufacturing controls, indicating a lack of robust procedures and oversight to ensure drug product quality and purity. These issues include inadequate investigations into out-of-specification results, manipulable environmental monitoring data, and deficient visual inspection and environmental monitoring procedures.

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## Related Officers

- [Dongping Dai](https://www.globalkeysolutions.net/people/dongping-dai/e3cd81c1-e1e8-4336-be62-45311c9d937b)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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

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