FDA 483 - WCM Waste & Compliance Management Inc - March 21, 2019

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.