FDA 483 - American Medical Endoscopy, Inc. - October 11, 2023

An FDA inspection of American Medical Endoscopy, Inc., a relabeler in Doral, FL, identified a significant procedural deficiency. The firm was cited for not having developed written Medical Device Reporting (MDR) procedures. This includes the absence of established guidelines for timeframes and necessary forms when the firm becomes aware of an MDR reportable event.