FDA 483 - WCM Waste & Compliance Management Inc - March 21, 2019
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An FDA inspection of WCM Waste & Compliance Management Inc in Carlsbad, CA, a manufacturer of the Class II Isolyzer/SMS sharps container device, revealed significant deficiencies in their quality system. Observations included uncontrolled production processes, uncalibrated equipment, and a lack of established procedures for rework, complaint handling, quality audits, and Medical Device Reporting (MDR). The firm also failed to adequately evaluate and approve key component vendors.
ID · 5726467f-409c-4efe-8fdb-bc1d78a57ccc