FDA 483 - Airsep Corporation - October 25, 2019

An FDA inspection of Airsep Corporation, a medical device manufacturer in Amherst, NY, revealed significant quality system deficiencies. The firm failed to adequately control nonconforming product, maintain a device master record, and properly document design review results for its Reliant PSA Oxygen Generator. These issues indicate a lack of adherence to regulatory requirements for medical device manufacturing.