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Endotec: Corrections and Removals

FDA’s inspection also revealed violations of the reports of corrections and removals regulation, including the following: ■    Failure to submit a written report to FDA of any correction or removal of a device initiated by a manufacturer to reduce a risk to health posed by a device, within 10 days of initiating such correction or removal.

?    Failure to include in the report of corrections and removals to FDA information on the device’s model, catalog, or code number and its manufacturing lot or serial number or other identification number.

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