FDA 483 - Suture Ease, Inc. - August 26, 2019

Suture Ease, Inc., a medical device manufacturer in San Jose, CA, was cited for a significant quality system deficiency related to its internal audit process. The inspection revealed that the individual responsible for Quality Assurance and Regulatory Affairs, who also handles complaint handling and CAPA, was conducting the firm's quality audits. This practice indicates a lack of auditor independence, raising concerns about the objectivity and effectiveness of the quality system oversight.