FDA 483 - Martech Medical Products, Inc. - February 12, 2015

Martech Medical Products, Inc. in Harleysville, PA, a medical device contract manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in documenting corrective and preventive actions, lacking written Medical Device Reporting procedures, inadequate supplier quality agreements, and poor complaint file maintenance, particularly concerning issues with breaking tunneler sleeves. These issues indicate a lack of robust controls over product quality, complaint handling, and regulatory reporting.