FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device

According to documents obtained through the Freedom of Information Act, the FDA “became aware” of the AGGA following a joint investigation by KFF Health News and CBS News in March 2023. Subsequently, the FDA conducted its first-ever inspection of Johns Dental months later.

The inspection revealed that Johns Dental failed to investigate customer complaints adequately, including those related to AGGA-related injuries. The FDA mandates that device companies investigate complaints and report them to the agency. Shockingly, Johns Dental had “never” alerted the FDA to any such complaints.

Full story at: https://kffhealthnews.org/news/article/fda-inspection-johns-dental-agga-device/view/republish/

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