483
TAYCA CORPORATIONFDA 483 - TAYCA CORPORATION - December 01, 2023
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An FDA inspection of Tayca Corporation, an API manufacturer in Okayama, Japan, revealed significant deficiencies in their cleaning validation procedures. The firm failed to periodically verify the effectiveness of validated cleaning procedures for non-dedicated equipment and lacked scientific data to support clean and dirty hold times. These issues indicate a lack of robust quality control in their manufacturing processes.
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ID · 72668c3b-2759-4c96-a26b-e182744f7871