483
Soma Technology IncFDA 483 - Soma Technology Inc - February 18, 2026
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Record Details
Soma Technology Inc., an importer of medical devices in Bloomfield, CT, was inspected by the FDA. The inspection revealed a significant failure to establish and implement written Medical Device Reporting (MDR) procedures, indicating a lack of compliance with federal regulations for device reporting. This could lead to unreported adverse events related to medical devices.
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