FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

FDA Cites Missouri Device Manufacturer for Complaint Files

Jan. 11, 2019

Devicemaker General Physiotherapy received a Form 483 for its handling of complaint files at its Earth City, Missouri facility.

Specifically, the firm is supposed to document complaints using its customer complaint verbal resolution form if the defective device isn’t returned. While the firm stated it received about ten complaints a year that don’t see devices returned, it hadn’t completed a verbal complaint form since May 2015.

The firm also didn’t document, on either return goods authorization forms or verbal complaint forms, if it evaluated the complaint to see if it should be reported to the FDA as part of medical device reporting.

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