# FDA 483 - Ajanta Pharma USA Inc - July 22, 2025

Source: https://www.keypedia.com/records/483/ajanta-pharma-usa-inc/a9671d7d-1ad1-4ff0-9f93-f1f64b6d9ec7

> FDA 483 for Ajanta Pharma USA Inc on July 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajanta Pharma USA Inc
- Inspection Date: 2025-07-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection conducted between July 15 and July 22, 2025, at an undisclosed pharmaceutical firm, identified a critical deficiency in post-marketing drug surveillance. The primary observation was the complete absence of written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences to the FDA. Specifically, the firm lacked established protocols for managing spontaneous, foreign, and expedited individual case safety reports (ICSRs). This lapse was noted despite the firm having commercialized various drug products internationally for several years. The inspection confirmed that no ICSRs related to these products had been surveyed, processed, or reported to the FDA since their initial commercialization. This non-compliance falls under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, which mandates robust post-market safety reporting to ensure public health. The firm is now required to develop and implement comprehensive written procedures for adverse event management and retrospectively address any unreported safety data to comply with federal regulations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/ajanta-pharma-usa-inc/fb94ebd3-ce80-4426-8f91-9f82716e5ea6

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248