FDA 483 - TCI CO., LTD. - BIOCOSME PABP BRANCH - March 13, 2026
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An FDA inspection of TCI Co., Ltd. - BioCosme PABP BRANCH in Pingdung County, Taiwan, revealed significant deficiencies in drug manufacturing practices. The firm failed to establish adequate production and process controls, including process validation and stability testing, and exhibited poor quality control unit adherence. Additionally, issues with component testing, supplier qualification, equipment cleaning, and facility sanitation were noted, indicating a broad lack of GMP compliance.
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