# FDA 483 - Sandoz Private Limited - January 22, 2024

Source: https://www.globalkeysolutions.net/records/483/sandoz-private-limited/a4c9e074-5b3a-41fc-a03e-155f1c8c0197

> FDA 483 for Sandoz Private Limited on January 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz Private Limited
- Inspection Date: 2024-01-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sandoz Private Limited in Hyderabad, India, received a Form 483 with three observations related to significant data integrity and quality system deficiencies. The firm failed to thoroughly investigate lost chromatographic data and lacked adequate oversight of GMP document management, including instances of document destruction. Additionally, the employee training program was found to be deficient, not ensuring employees' familiarity with CGMP requirements.

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/sandoz-private-limited/3d0f0519-e836-4300-9178-8925d5820fd8

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