FDA 483 - Moog Costa Rica, SRL - November 01, 2018

Moog Medical Devices Group, Srl in Alajuela, Costa Rica, a medical device manufacturer, received two observations during an FDA inspection. The firm's procedures for controlling environmental conditions in its cleanroom, including bioburden monitoring and employee gowning, were found to be inadequate. Additionally, the supplier evaluation system was deemed insufficient, as it allowed poorly performing suppliers to meet expectations.