FDA 483 - Teva Pharmaceutical Industries Ltd. - May 23, 2023

Teva Pharmaceutical Industries Ltd. in Kfar Saba, Israel, received a Form 483 with five observations during an inspection of its human drug manufacturing facility. The inspection revealed significant deficiencies in equipment cleaning and maintenance, cleaning validation, and procedures for ensuring equipment cleanliness. Additionally, the firm failed to thoroughly review unexplained discrepancies and exhibited inadequate procedures for preventing microbiological contamination in sterile drug products, including issues with disinfection, aseptic area behavior, and disinfectant efficacy qualification. Finally, the aseptic processing areas were found deficient in environmental and personnel monitoring programs.