The FDA cited a Genesee BioMedical facility in Denver, Colorado for not reporting corrective actions or properly calibrating equipment.
The agency issued a Form 483 after a February 2018 inspection noting the company failed to report a correction to the Instructions for Use labeling of its Class I sternal retractor devices to fix a known health risk after receiving a complaint from a customer who had undergone during heart surgery. The company also failed to keep on file a justification for why the correction was not reportable.
Investigators also found that the company did not adequately validate its impulse heat sealer to simulate equipment operating conditions during the packaging process.
Investigators also observed a spreadsheet that was not defined in the facility’s calibration procedure being used to track upcoming calibration dates.