FDA 483 - ImpactOrtho Inc - February 06, 2025

ImpactOrtho Inc, an HCT/P distributor in Tempe, AZ, was cited for significant deficiencies during an FDA inspection. Observations included a failure to record and maintain storage temperatures for HCT/P products, an inadequate quality program lacking procedures for temperature alarm investigations, and non-adherence to equipment maintenance procedures, specifically regarding freezer qualification and alarm checks. These issues indicate a lack of control over critical storage conditions for distributed HCT/Ps.