FDA 483 - EHOB, Inc. - May 06, 2019

EHOB, Inc. in Indianapolis, IN, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately validate its welding processes, establish consistent complaint handling procedures, and implement proper Medical Device Reporting (MDR) protocols. These issues indicate a lack of robust controls over manufacturing processes, complaint management, and regulatory reporting requirements.