MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.