483
Albahealth LLCFDA 483 - Albahealth LLC - March 17, 2022
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Record Details
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.
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ID · 127fde6d-e972-47b8-88cc-b2960de96644