483
Synapse DentalSynapse Dental – FDA 483, Nov 1, 2021
Record Details
An FDA inspection of Synapse Dental in Cranston, RI, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design changes, acceptance activities, and complaint handling. These issues indicate a lack of robust controls over product design, incoming materials, and post-market surveillance for their Synapse Dental Pain Eraser device.
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ID · 27318b4f-c4ab-445d-955b-83f198d14d75
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