FDA 483 - Tayca Corporation

Tayca Corporation, an API manufacturer in Okayama, Japan, was inspected by the FDA, revealing a significant issue with following established procedures. The firm failed to document the extended time needed to propose corrective actions for out-of-specification results, taking 14 months to address issues from long-term stability tests. This indicates a lapse in adherence to their CAPA procedure and overall quality management system.