FDA 483 - Conod Medical Co., Limited - May 30, 2013

Conod Medical Co., Limited, a medical device manufacturer in Changshu, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate process validation for catheter tubing, a lack of established corrective and preventive action procedures, and sampling plans not based on valid statistical rationale. These issues indicate a failure to ensure product quality and address nonconformities effectively.