GMP, MDR Violations Cited in Warning Letter to PMT

Problems with good manufacturing practices (GMPs) and medical device reports (MDRs) led to a warning letter for PMT Corp., which makes a variety of devices, including neurosurgical electrodes, traction systems and gel shapes for scar treatment. The letter, which stems from a July inspection of PMT’s Chanhassen, Minn., plant, cites five GMP violations, including failure to adequately validate processes when the results cannot be fully verified by an inspection and test. Eric Caille, PMT’s regulatory manager, said he expects the warning letter to be closed out Jan. 9 as all the observations have been addressed.
Devices & Diagnostics Letter