FDA 483 - SpaceBander Corporation - May 27, 2025

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.