# FDA 483 - SpaceBander Corporation - May 27, 2025

Source: https://www.globalkeysolutions.net/records/483/spacebander-corporation/c415cdfa-18e3-4fc0-8855-b3b2d937f4ef

> FDA 483 for SpaceBander Corporation on May 27, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SpaceBander Corporation
- Inspection Date: 2025-05-27
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of SpaceBander Corporation, a medical device manufacturer in Hillsborough, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately maintain device history records, establish procedures for purchased product and supplier controls, and implement procedures for non-conforming products. These observations indicate a lack of robust quality assurance practices for their Spacebander device.

## Related Documents

- [483 - 2022-06-02](https://www.globalkeysolutions.net/records/483/spacebander-corporation/d70568f0-f80f-410c-8f74-0a4a8f347d9d)

## Related Officers

- [Frank J. Marciniak](https://www.globalkeysolutions.net/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

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

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