FDA 483 - Teva Puerto Rico LLC - November 23, 2022

Teva Puerto Rico LLC, a drug product manufacturer in Fajardo, PR, was cited for significant deficiencies in its laboratory control systems. The inspection revealed that the firm failed to establish the accuracy and reproducibility of test methods for drug product degradation and did not thoroughly investigate out-of-specification results. These issues indicate a lack of robust quality control and data integrity in their manufacturing processes.