SoClean, Inc – FDA EIR, Sep 26, 2012

An FDA inspection of Inceptus, Inc., a Class I medical device manufacturer in Uxbridge, MA, occurred from September 24 to September 26, 2012. This initial, routine inspection focused on the company's management controls, complaint handling processes, and reporting requirements for its SoClean CPAP Sanitizing System. The inspection revealed four key deficiencies, outlined in an FDA-483 report. Inceptus had not conducted internal quality audits to assess its quality system, nor had it established formal procedures for such audits. Additionally, the company lacked established procedures for systematically receiving, reviewing, and evaluating customer complaints. Crucially, written procedures for Medical Device Reporting (MDR), which are critical for reporting adverse events related to medical devices, had not been developed. These observations highlight gaps in Inceptus's adherence to fundamental medical device quality system regulations. In response, company management committed to establishing and implementing the required quality audit procedures, comprehensive complaint handling processes, and written Medical Device Reporting procedures within 60 to 90 days to rectify these compliance issues.