483
dBMEDx, IncFDA 483 - dBMEDx, Inc - March 27, 2025
Record Details
dBMEDx, Inc., a medical device manufacturer in Littleton, CO, was cited for two observations during an FDA inspection. The firm failed to adequately validate a process for testing its BBS Revolution ultrasound devices and did not establish proper procedures for acceptance activities. These issues indicate deficiencies in process control and quality system documentation.
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ID · b55df468-1e40-4394-858a-d0e728362286