# FDA 483 - Sun Pharmaceutical Industries Limited - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/sun-pharmaceutical-industries-limited/91b1aeaa-7c53-4a53-bce1-a8443bffca39

> FDA 483 for Sun Pharmaceutical Industries Limited on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Limited
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Sun Pharmaceutical Industries Limited in New Delhi, India, was cited during an FDA inspection of its Biopharmaceutics Clinical Facility for significant data integrity and submission issues. The firm failed to include critical addendums to clinical study reports in an abbreviated new drug application and could not provide original electronic study documentation for review due to a global information security incident. These observations indicate deficiencies in data management and regulatory submission practices.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/sun-pharmaceutical-industries-limited/b23bf4bd-3ff1-48bb-b06c-5e2724098d1a)
- [WARNING_LETTER - 2023-12-15](https://www.globalkeysolutions.net/records/warning_letter/sun-pharmaceutical-industries-limited/4ef94056-dc34-4d6c-b547-854e573109f6)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/sun-pharmaceutical-industries-limited/9571fd28-2dde-4d28-a63b-9291b4c22d22)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/sun-pharmaceutical-industries-limited/99d892ac-0b5d-40a2-a414-38ea094398c4)

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.globalkeysolutions.net/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.globalkeysolutions.net/companies/sun-pharmaceutical-industries-limited/c04f5abc-1108-4541-baed-84d7018e3646

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4