PMT Expects Closeout Soon of GMP Warning Letter

Problems with 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 22 to Aug. 4 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 that the FDA has accepted its corrective plan for this observation. He expected the warning letter to be closed out this month as all the other observations have been satisfactorily addressed.
The GMP Letter