FDA EIR - Euclid Systems Corporation - February 21, 2019

An FDA inspection of Euclid Systems Corporation, a manufacturer of Class II and Class III medical devices (contact lenses) located in Sterling, VA, was conducted from February 19 to February 21, 2019. This abbreviated Level I QSIT inspection focused on Corrective and Preventive Actions (CAPA) and Production and Process Controls, adhering to Compliance Program 7383.845 for medical device manufacturers. The inspection confirmed the satisfactory resolution of four significant observations from a previous inspection in March 2018. These prior issues included inadequate process validation, deficiencies in corrective and preventive action procedures, insufficient controls for purchased products and services, and a lack of established procedures for equipment calibration and maintenance. Euclid Systems Corporation demonstrated that these areas had been effectively addressed through updated procedures and verified corrective actions. During the current inspection, no new inspectional observations (FDA-483) were issued. However, a discussion with management highlighted a need to amend the CAPA procedure to include a step for ensuring the timely closure of corrective and preventive actions. The company's management committed to incorporating this improvement into their quality system, indicating overall compliance with regulatory requirements for medical device manufacturing.