# FDA 483 - AirScan Inc. d/b/a HemaTechnologies - March 24, 2023

Source: https://www.keypedia.com/records/483/airscan-inc-dba-hematechnologies/f2416853-ed22-440d-a6c6-17b88d2e1b10

> FDA 483 for AirScan Inc. d/b/a HemaTechnologies on March 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AirScan Inc. d/b/a HemaTechnologies
- Inspection Date: 2023-03-24
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AirScan Inc. d/b/a HemaTechnologies in Lebanon, NJ, identified nine significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for critical areas such as complaint handling, rework, corrective and preventive actions, and vendor management. These observations indicate a broad lack of adherence to quality system requirements for their medical devices.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/airscan-inc-dba-hematechnologies/9a63713a-2f50-47ba-a5c8-80aed7405435

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248