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

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.