FDA 483 - Teva Biotech GmbH - March 13, 2025

Teva Biotech GmbH in Ulm, Germany, a drug substance manufacturer, was cited for significant deficiencies across its manufacturing processes, laboratory controls, and facility maintenance. The inspection revealed issues with process validation, facility design, data integrity, adherence to and adequacy of procedures, and various qualification and validation activities. These observations indicate a broad range of concerns regarding the firm's ability to ensure the quality and integrity of its drug substance products.