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.
Out of 136 complaints reviewed during the inspection, the company had not evaluated any to see if an investigation was necessary. “It does not appear investigations were performed for any of these complaints,” it adds.
The company apparently did not record verbal complaints at all, the letter said.
General Medical’s corrective and preventive action file noted several events where customers were not aware of precautions for the devices. However, the company did not identify actions that would prevent and correct this issue. Several complaints involved customers who were unaware of contraindications for people with metal implants.
According to the letter, the company had not conducted any management reviews or quality audits from 2013 to 2015, despite its procedures requiring these audits annually.
Meanwhile, it failed to conduct adequate revalidations in 2011 after moving certain manufacturing processes from Los Angeles to Pasadena, Calif. The revalidation should have included qualifying the installation and operation of certain equipment.
In addition, the firm failed to maintain a device master record, and it didn’t maintain device specifications, including component specifications, production methods and procedures, and quality assurance procedures and specifications.
It also lacked records of receiving, in-process or final acceptance activities for certain devices prior to release for distribution, including documentation that they passed final testing.
Further citations related to process validation, device history records. For example, the firm’s device history records didn’t include the dates of manufacturing, quantity manufactured and released for distribution, or the unique device identifier.
Additionally, the Drionic Hand/Foot and Drionic Armpit iontophoresis devices lack approval or clearance, and the agency deemed the devices misbranded.