FDA 483 - Allison Medical, Inc. - April 28, 2023

Allison Medical, Inc. in Littleton, CO, was inspected from April 25-28, 2023, and received four observations. The inspection revealed significant deficiencies in their quality system, including inadequate MDR event files, poorly established corrective and preventive action procedures, unvalidated custom software, and insufficient document control practices. These findings indicate a moderate level of non-compliance, with one observation being a repeat finding.