Representation of Southeastern Health System in Navigating FDA Investigation

We represent a Southeastern health system in responding to an investigation by the FDA, following notification by a manufacturer of possible diversion at the hospital. We guided the hospital through an internal investigation of the possible diversion and assist in responding to inquiries from and producing records to the FDA. We also advise the health system in a review of its controlled substance compliance measures and process improvements that will advance its ability to prevent and detect diversion, including staff education and policy enhancements.

We represent a Southeastern health system in responding to an investigation by the FDA, following notification by a manufacturer of possible diversion at the hospital. We guided the hospital through an internal investigation of the possible diversion and assist in responding to inquiries from and producing records to the FDA. We also advise the health system in a review of its controlled substance compliance measures and process improvements that will advance its ability to prevent and detect diversion, including staff education and policy enhancements.