The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, AGGA, a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.
The company didn't require all customer complaints to be investigated, and some complaints about people being hurt by its products, including the AGGA, were not investigated or reported to the FDA.
The AGGA's claims of being able to grow or expand an adult's jaw without surgery and treat ailments were not scientifically supported. Johns Dental settled lawsuits from 20 patients alleging harm from the AGGA.
Former FDA officials highlighted the lack of inspections and investigations at Johns Dental as the reason the AGGA stayed off the FDA's radar for so long. The company's failure to report any complaints raised concerns.
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