FDA 483 - Euromed, Inc. - March 03, 2020

Euromed, Inc. in Orangeburg, NY, a medical device manufacturer, was inspected by the FDA from February 26 to March 3, 2020. The inspection revealed significant deficiencies in quality system procedures, including a lack of internal quality audits, inadequate employee clothing requirements in cleanrooms, and poorly established procedures for in-process and finished device acceptance testing. These issues indicate a lack of robust quality control for sterile wound care dressings and adhesive tapes.