# FDA 483 - Ajanta Pharma Limited - June 22, 2019

Source: https://www.globalkeysolutions.net/records/483/ajanta-pharma-limited/23118fab-e9e6-49e2-a00d-e4d36a5e883e

> FDA 483 for Ajanta Pharma Limited on June 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajanta Pharma Limited
- Inspection Date: 2019-06-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ajanta Pharma Limited, a drug products manufacturer in Bharuch, Gujarat, India, was cited for significant deficiencies in its quality system and laboratory controls during an FDA inspection. Observations included a failure to thoroughly investigate market complaints regarding product odor and potential contamination, as well as inadequate oversight of contract laboratory data and a lack of testing for leachable and extractables in primary packaging components. These issues indicate a potential risk to product quality and patient safety.

## Related Documents

- [483 - 2022-09-09](https://www.globalkeysolutions.net/records/483/ajanta-pharma-limited/a96c64a0-ac89-4640-8e1f-3c3a54d0fbdb)

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [Kshitij A. Patkar](https://www.globalkeysolutions.net/people/kshitij-a-patkar/feaedcad-cb5c-4179-995e-d96af0bc9278)

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