# FDA 483 - Ajanta Pharma Ltd. - April 21, 2026

Source: https://www.keypedia.com/records/483/ajanta-pharma-ltd/0e2e1c27-f6e4-4890-be38-fd6f38fc3be6

> FDA 483 for Ajanta Pharma Ltd. on April 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajanta Pharma Ltd.
- Inspection Date: 2026-04-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Ajanta Pharma Ltd. in Paithan, India, revealed five significant observations concerning deficiencies in their quality control and manufacturing operations. The firm failed to adequately support drug product shelf-life with stability data, conduct thorough investigations into out-of-specification results, and maintain equipment properly. Additionally, the inspection found that written production procedures were not followed, and manufacturing equipment was not adequately qualified, indicating a lack of robust quality systems.

## Related Documents

- [483 - 2019-06-28](https://www.keypedia.com/records/483/ajanta-pharma-ltd/15e08bf4-14a3-4a50-a9be-2ac0598f15bb)

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/ajanta-pharma-ltd/040efb87-46b2-4747-b87d-c1d87daad1e7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8