FDA 483 - Tayca Corporation - August 25, 2023

An FDA inspection of Tayca Corporation's API manufacturing facility in Okayama, Japan, conducted from August 21 to August 25, 2023, identified significant procedural non-compliance. The FDA Form 483 issued to General Manager Hiroji Okamoto detailed an observation regarding the firm's failure to consistently follow its own established procedures for corrective actions. Specifically, the inspection found that proposed corrective actions for two Out-of-Specification (OOS) results (00000103_220018 and 00000), identified in June 2022 during a long-term stability test, were not submitted until August 11, 2023—a delay of 14 months. This directly contravenes the company's CAPA Procedure, GMP-QA-4-004(05), which requires a plan to be prepared and reported to the QA Manager when corrective action time limits are exceeded. This observation falls under the regulatory framework of Section 704(b) of the Federal Food, Drug and Cosmetic Act. Tayca Corporation is required to promptly address these findings by implementing effective corrective and preventive actions to ensure compliance with its procedures and regulatory expectations for timely resolution of quality issues.