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

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FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation. According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later. That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some com

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