FDA EIR - Teva Parenteral Medicines, Inc. - August 30, 2019

An FDA inspection of Teva Parenteral Medicines, Inc. in Irvine, CA, was conducted from August 26-30, 2019. This routine comprehensive inspection covered current Good Manufacturing Practices (cGMP), pre-approval processes for Romidepsin Injection, and the drug quality reporting system, adhering to Compliance Programs 7356.002A, 7346.832, and 7356.021. The inspection identified several significant issues, leading to a 6-item Form FDA 483. Main violations included the failure to submit an NDA-Field Alert Report within the required three working days, and inadequate investigations into complaints concerning particulates and lack of product effectiveness. Inspectors also found insufficient training and qualification for personnel involved in visual inspection. Furthermore, the frequency and duration of simulated interventions during media fill studies were not adequately based on historical data. Other deficiencies involved vial washer validation lacking downtime evaluation, and improper storage of microbiological media used for surface monitoring, with no established time limits for incubation after sampling. Management, represented by Angela J. Swanton, Site General Manager, received the Form FDA 483 at the inspection's close. They committed to submitting a written response detailing corrective actions to the Agency within 15 business days.