FDA 483 - Arjo, Inc. dba ArjoHuntleigh - December 02, 2021

Arjo, Inc. dba ArjoHuntleigh, a medical device importer in Addison, IL, was cited for deficiencies in its complaint handling procedures during an FDA inspection. The firm's global procedures were found to be inconsistent with local instructions, and evaluations for Medical Device Reports (MDRs) were not adequately conducted or documented within required timeframes. This indicates a significant issue with their quality system regarding post-market surveillance.