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

An FDA inspection was conducted at Teva Pharmaceuticals USA, Inc.'s corporate office in Parsippany, NJ, from September 26 to September 29, 2023. The inspection identified a significant observation documented on an FDA Form 483. The primary issue cited was the company's failure to maintain comprehensive drug distribution and dispensing records as mandated by its approved Risk Evaluation and Mitigation Strategy (REMS) Implementation System. Specifically, Teva Pharmaceuticals did not collect required dispensing records from certified inpatient pharmacies, which is essential for ensuring the restricted distribution of a drug under its REMS program. This omission indicates a lapse in critical record-keeping practices designed to control access to specific medications and ensure patient safety. To address this observation, Teva Pharmaceuticals is expected to review and enhance its record collection processes for drug distribution and dispensing, particularly from inpatient pharmacies, to ensure full adherence to its approved REMS and associated regulatory requirements. This will involve implementing corrective actions to ensure proper oversight and documentation of restricted drug distribution.