Tianjin Kingyork Pharmaceuticals Co., Ltd – FDA 483, Jul 31, 2026
The FDA inspection of Tianjin Kingyork Pharmaceuticals Co., Ltd. in Tianjin revealed critical deficiencies in aseptic processing and quality control for sterile drug products. The firm exhibited inadequate validation of aseptic processes, including airflow, decontamination, and sterile filling machine qualification, alongside issues with media fills and in-process controls. Furthermore, the company failed to establish and follow proper procedures for preventing microbiological contamination, investigating discrepancies, and ensuring qualified personnel for visual inspection and cleaning practices.
ID · 21301a7a-58e2-4a9f-a4f8-0775d5eb7f47
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