Spectranetics Corporation

Warning letter issued May 23, 2016

Inspection
Nov 30, 2015 – Jan 21, 2016
Pages
8

In short: On May 23, 2016, FDA sent a warning letter to Spectranetics Corporation.

Inside this warning letter

The full warning letter

Every page of the warning letter, exactly as written.

Get the full warning letter

This inspection in context

Questions about this warning letter

When was Spectranetics Corporation inspected by FDA?

The inspection ran Nov 30, 2015 – Jan 21, 2016, and the Warning letter is dated May 23, 2016.

How do I get the full Warning letter for Spectranetics Corporation?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

$99Get it free
Spectranetics Corporation FDA Warning Letter (May 2016) | FDA Intel