FDA 483 - Sekisui Medical Co., Ltd. - June 17, 2016

On June 17, 2016, an FDA Form 483 was issued to Sekisui Medical in Iwate, Japan, following an inspection. The inspection revealed significant deviations from current Good Manufacturing Practice (cGMP) regulations for medical devices.

The primary observation noted was a failure to adequately establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). Specifically, the firm's CAPA procedures were found to be deficient in several areas. There was no clear requirement for the investigation of the cause of nonconformities relating to product, processes, and the quality system. Furthermore, the procedures did not ensure that the effectiveness of the CAPA was verified or validated. This deficiency impacts the firm's ability to effectively address and prevent recurrence of quality issues, potentially affecting product quality and patient safety. The lack of robust CAPA procedures indicates a weakness in the overall quality system, which could lead to recurring manufacturing and product issues.