FDA 483 - Albahealth LLC - March 17, 2022

An FDA inspection of Albahealth LLC in Rockwood, TN, conducted from March 15-17, 2022, identified a significant documentation deficiency. The firm failed to fully document rework and reevaluation activities in the device history record. This included a lack of documented review and disposition for nonconforming products, such as unsealed compression stocking bags.