General Medical Lands Warning Letter Over Complaint Handling, QS Failures

General Medical Company, a maker of devices for excessive sweating, did not keep a record of verbal complaints and had problems with its complaint evaluations, the FDA found during an October 2015 inspection.

The Pasadena, Calif., company manufactures and distributes OTC iontophoresis devices, which use a direct current to treat hyperhidrosis in the underarms, hands and feet.

 Two complaints — one involving a customer with a prolonged rash and one where a customer said his daughter’s hand was burned by a device — were not evaluated for reportability, says the June 2 letter, posted online June 28.