FDA 483 - Medical Components, Inc dba MedComp - June 14, 2017

An FDA inspection of Medical Components, Inc dba MedComp in Harleysville, PA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately document and implement corrective and preventive actions, particularly concerning supplier issues. Additionally, the inspection found a lack of required quality audits, insufficient evaluation of potential suppliers, and untimely investigation of nonconforming products, indicating systemic control breakdowns.