FDA 483 - Microvapor Devices LLC - July 18, 2025

An FDA inspection of Microvapor Devices LLC in West Columbia, SC, revealed seven significant observations regarding their manufacturing processes for Class II medical devices, including the Pocket Nebulizer. Deficiencies were noted in design validation, labeling control, device master records, equipment calibration, complaint handling, device history records, and incoming product acceptance. These issues collectively indicate a lack of adherence to established quality system regulations.