# FDA 483 - Shiva Analyticals (India) Pvt. Ltd. - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/shiva-analyticals-india-pvt-ltd/e4971176-fb62-4af2-9c59-cf6938aa5dc1

> FDA 483 for Shiva Analyticals (India) Pvt. Ltd. on January 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shiva Analyticals (India) Pvt. Ltd.
- Inspection Date: 2025-01-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shiva Analyticals (India) Pvt. Ltd., a contract testing laboratory in Hoskote Bangaluru, revealed significant deficiencies across its quality control unit. Observations included widespread data integrity issues, inadequate analytical method validation, and a failure to thoroughly investigate discrepancies and customer complaints. These findings indicate a severe lack of oversight and adherence to cGMP principles.

## Related Documents

- [483 - 2016-02-24](https://www.globalkeysolutions.net/records/483/shiva-analyticals-india-pvt-ltd/617bf306-ae11-4cec-b73e-73262ea5e476)
- [483 - 2025-01-24](https://www.globalkeysolutions.net/records/483/shiva-analyticals-india-pvt-ltd/465245e1-14b1-4d1a-9ac5-f913490d31dd)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/shiva-analyticals-india-pvt-ltd/e0fbc63a-6926-4388-9268-dab31714e1a1

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