# FDA 483 - Pierre Fabre Pharmaceuticals, Inc. - November 01, 2024

Source: https://www.globalkeysolutions.net/records/483/pierre-fabre-pharmaceuticals-inc/93bd2e29-071a-4aa5-b251-f87b6344aba2

> FDA 483 for Pierre Fabre Pharmaceuticals, Inc. on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pierre Fabre Pharmaceuticals, Inc.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Pierre Fabre Pharmaceuticals, Inc. in Parsippany, NJ, revealed significant deficiencies in adverse drug experience reporting. The firm failed to report a substantial number of serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. Additionally, individual case safety reports (ICSRs) submitted by the firm lacked complete and accurate initial reporter information, including name, address, telephone number, and healthcare professional status.

## Related Officers

- [Meredith L. Miller](https://www.globalkeysolutions.net/people/meredith-l-miller/c775003b-4e5b-48d8-bc51-1a3ebe813dba)

Company: https://www.globalkeysolutions.net/companies/pierre-fabre-pharmaceuticals-inc/ee0282e8-44f7-43c1-b3d5-fdc0c75129dc

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