The FDA hit Carlsbad, California devicemaker WCM Waste and Compliance Management with a Form 483 over issues with its calibration procedures.

During their March 15-21 inspection, the investigator noted that equipment used to manufacture the firm’s Class II Isolyser/SMS sharps container device, which is used for the disposal of sharp medical products, was not routinely calibrated.

For example, the inspector discovered that a thermometer used to test the quality of the devices had not been calibrated since at least 2012.