FDA 483 - Teva Parenteral Medicines, Inc. - January 18, 2019

An FDA inspection of Fera Parenteral Manufacturing in Irvine, CA, revealed significant deficiencies across multiple areas. The firm lacked adequate written procedures for production and process controls, failed to follow established procedures, and exhibited poor laboratory control mechanisms. Additionally, the accuracy, specificity, and reproducibility of test methods for drug products were not properly established.