FDA EIR - Eagle Medical Inc - July 13, 2017

An FDA inspection of Eagle Medical Inc., a contract packager and sterilizer of Class II sterile medical devices in Paso Robles, CA, was conducted from July 11 to July 13, 2017. This was a for-cause FDA inspection of Eagle Medical Inc., a contract packager and sterilizer of Class II sterile medical devices, conducted under Compliance Program 7382.845. The inspection focused on the Corrective and Preventive Action (CAPA) and Production and Process Controls subsystems, including sterilization processes.

Eagle Medical operates as a contract labeler, packager, and sterilizer and does not own or market products under its own name. The firm is FDA-registered, ISO 13485 certified, and has had no recalls since the previous inspection. The prior FDA inspection (April 27, 2016) was classified as NAI (No Action Indicated).