FDA 483 - Allison Medical, Inc. - July 29, 2022

Allison Medical, Inc. in Littleton, CO, an importer of medical devices, was issued a Form FDA 483 with seven observations following an inspection. The firm demonstrated significant deficiencies in its quality system, including failures in reporting device recalls and serious injury events (MDRs) to the FDA. Additionally, procedures for complaint handling, corrective and preventive actions, supplier control, acceptance activities, and document control were found to be inadequately established.