FDA 483 - Oral 7 USA Operations, Inc. - December 09, 2021

During an FDA inspection, Oral 7 USA Operations, Inc., a medical device firm in New York, NY, was cited for failing to establish written procedures for electronic Medical Device Reporting (eMDR). The firm also did not set up an Electronic Submissions Gateway (ESG) account, which is necessary for reporting serious injuries and deaths related to medical devices. This indicates a significant lapse in their quality system regarding post-market surveillance.