# FDA 483 - SpaceBander Corporation - June 02, 2022

Source: https://www.keypedia.com/records/483/spacebander-corporation/d70568f0-f80f-410c-8f74-0a4a8f347d9d

> FDA 483 for SpaceBander Corporation on June 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpaceBander Corporation
- Inspection Date: 2022-06-02
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of SpaceBander Corporation in Hillsborough, NJ, revealed significant deficiencies in their quality system for medical devices. The firm failed to establish procedures for corrective and preventive actions, purchasing controls for their contract manufacturer, and document control. These issues indicate a lack of fundamental quality management processes.

## Related Documents

- [483 - 2025-05-27](https://www.keypedia.com/records/483/spacebander-corporation/c415cdfa-18e3-4fc0-8855-b3b2d937f4ef)

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/spacebander-corporation/d864169a-73a5-4fc8-ac44-370c9f56374e

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