# FDA 483 - Airsep Corporation - October 25, 2019

Source: https://www.globalkeysolutions.net/records/483/airsep-corporation/7ab023b0-83d9-43f8-8467-8aa1e4c3157b

> FDA 483 for Airsep Corporation on October 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Airsep Corporation
- Inspection Date: 2019-10-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)
- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/airsep-corporation/b17b062c-b5b4-4065-82d0-6722897a6e7d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961