FDA 483 - Atrium Medical Corporation - September 06, 2022

Atrium Medical Corporation in Merrimack, NH, was cited for significant deficiencies in its medical device manufacturing processes. The inspection revealed inadequate design input procedures, insufficient process validation, and failures in contamination control for water systems, which contributed to Class I and Class II recalls for their iCast/Advanta V12 stents and Pneumostat Chest Drain. Additionally, the firm demonstrated inadequate documentation of corrective and preventive actions and failed to investigate complaints within established timeframes.