FDA 483 - Teva Pharmaceuticals USA, Inc - September 29, 2023

Teva Pharmaceuticals USA, Inc. in Parsippany, NJ, was cited for failing to maintain adequate drug distribution and dispensing records related to its approved REMS Implementation System. Specifically, the firm did not collect dispensing records from certified inpatient pharmacies. This lapse prevented the company from ensuring restricted distribution of its drug products.