# FDA 483 - Areva Pharmaceuticals Inc - September 11, 2025

Source: https://www.globalkeysolutions.net/records/483/areva-pharmaceuticals-inc/46f621ae-3fe5-4c81-b4c0-c383d3632512

> FDA 483 for Areva Pharmaceuticals Inc on September 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Areva Pharmaceuticals Inc
- Inspection Date: 2025-09-11
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Areva Pharmaceuticals Inc in Georgetown, IN, revealed significant issues with regulatory reporting and pharmacovigilance procedures. The firm failed to submit annual reports and periodic adverse drug experience reports (PADERs) in a timely manner, with some PADERs being entirely missing. Additionally, written procedures for evaluating and reporting post-marketing adverse drug experiences, including the use of third-party vendors, were found to be insufficiently detailed.

## Related Officers

- [Iris C. Macinnes](https://www.globalkeysolutions.net/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)

Company: https://www.globalkeysolutions.net/companies/areva-pharmaceuticals-inc/175c1789-397d-48ca-b884-d376f3118290

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03