FDA 483 - Tayca Corporation - December 15, 2017

Tayca Corporation, a non-sterile API manufacturer in Okayama, Japan, was cited for significant deficiencies in its quality control unit, including inadequate investigations into out-of-specification results and communication errors, and failure to verify USP assay methods. The inspection also revealed issues with data integrity due to a lack of audit trails in analytical software, poor facility and equipment cleaning, and insufficient calibration and traceability for production equipment and materials. These observations indicate a systemic lack of robust quality management practices impacting product quality and data reliability.