Airsep CorporationOctober 25, 2019

FDA 483 - Airsep Corporation - October 25, 2019

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Record Details

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.

Company: Airsep Corporation
Inspection Date: October 25, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
People: Wendy M. Stone (investigator)
Matthew D. Schnittker

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ID · 7ab023b0-83d9-43f8-8467-8aa1e4c3157b