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 made a correction to 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 failed to report the correction in writing to the FDA and it did not 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.
The agency investigator found that the sealer equipment was labeled with an expired calibration interval. Moreover, the form states, the calibration procedure documentation did not define how it tracks calibration due dates, and personnel could not locate spreadsheets tracking calibration in previous years.
Investigators also observed a spreadsheet that was not defined in the calibration procedure being used to track upcoming calibration dates in 2018.