Teva Pharmaceutical Industries, Ltd. – FDA 483, 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.
- Office
- Human Foods Program
- Person
ID · 1885616a-cc25-43ec-bc55-d76cb3d073b3
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