Canon USA Gets Warning Letter for MDR Reporting Violations

Improper MDR procedures at a Canon USA factory in Irvine, Calif., noted during a June 12 to July 23 inspection, landed the company an FDA warning letter. Inspectors from the Los Angeles district office criticized Canon’s written MDR procedures, saying they were rife with undefined terms and did not properly establish internal systems for a standardized review process. In addition, the MDR procedure did not explain how to obtain and complete the FDA 3500A form, the Jan. 7 letter states.
Devices & Diagnostics Letter