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

Source: https://www.globalkeysolutions.net/records/483/shiva-analyticals-india-pvt-ltd/465245e1-14b1-4d1a-9ac5-f913490d31dd

> 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 Inspections and Investigations
- Summary: The FDA inspection of Shiva Analyticals (India) Pvt. Ltd. in Hoskote Bangaluru revealed significant deficiencies across its quality control and assurance units. The firm failed to maintain data integrity, lacked scientifically sound analytical test procedures, and conducted inadequate investigations into laboratory discrepancies and customer complaints. These issues indicate a severe breakdown in the firm's overall quality systems.

## 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/e4971176-fb62-4af2-9c59-cf6938aa5dc1)

## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8