FDA 483 - Blue Belt Technologies - February 06, 2020

Blue Belt Technologies, a medical device specification developer in Pittsburgh, PA, received an FDA Form 483 citing significant deficiencies in its quality system. The inspection revealed widespread failures in Medical Device Reporting (MDR), including not submitting reports for serious injuries and malfunctions, and inadequate documentation for non-reportable decisions. Additionally, the firm was cited for insufficient corrective and preventive actions and incomplete risk analyses related to its NAVIO surgical system.