FDA 483 - VistaMed Ltd t/a Freudenberg Medical - November 16, 2016

Alstamed Ltd, a manufacturer of micro infusion catheters, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately control non-conforming products, releasing multiple lots of catheters despite documented visual, functional, and dimensional non-conformances. Additionally, the company did not document corrective and preventive action activities or results, even when critical effects and trends of non-conformities occurred.