Wound Healing Technologies – FDA 483, Mar 2, 2022

Wound Healing Technologies, a medical device distributor in Brooklyn, NY, received a Form 483 with four observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including the absence of established procedures for servicing activities, incoming product acceptance, complaint handling, and Medical Device Reporting (MDR). These findings indicate a lack of fundamental controls necessary for ensuring device quality and post-market surveillance.