FDA 483 - Ekcomed LLC - August 08, 2019

Ekcomed, LLC, a medical device specification developer in Saint Charles, MO, received a Form FDA 483 citing significant quality system deficiencies. The firm lacked established procedures for contamination prevention, adequate supplier quality agreements, and proper investigation of product complaints. Additionally, Ekcomed had no written Medical Device Reporting (MDR) procedures and failed to document employee training.