# FDA 483 - Ajanta Pharma Limited - September 09, 2022

Source: https://www.globalkeysolutions.net/records/483/ajanta-pharma-limited/a96c64a0-ac89-4640-8e1f-3c3a54d0fbdb

> FDA 483 for Ajanta Pharma Limited on September 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajanta Pharma Limited
- Inspection Date: 2022-09-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection, Ajanta Pharma Limited in Bharuch, India, a human drug manufacturer, was cited for two significant issues. The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding tablet anomalies and unqualified visual inspection equipment. Additionally, the company lacked appropriate controls over computer systems, with critical software for tablet manufacturing equipment not being validated in accordance with established procedures, including 21 CFR Part 11 compliance.

## Related Documents

- [483 - 2019-06-22](https://www.globalkeysolutions.net/records/483/ajanta-pharma-limited/23118fab-e9e6-49e2-a00d-e4d36a5e883e)

## Related Officers

- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/ajanta-pharma-limited/fd7fa3df-aad1-4a87-a41a-c75107fec4d6

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