FDA 483 - Teva Pharmaceutical Industries, Ltd. - May 24, 2023

Teva Pharmaceutical Industries, Ltd. in Boone, NC, was cited for significant deficiencies in its manufacturing processes for human drugs, including sterile and non-sterile products. The inspection revealed widespread issues with equipment cleaning and maintenance, inadequate procedures for pre-use cleanliness inspection, failure to investigate batch discrepancies, and critical lapses in preventing microbiological contamination in aseptic areas. These findings indicate a high severity of non-compliance with cGMP regulations.