Roche Diagnostics GmbH

Warning letter issued February 5, 2003 · Indianapolis, Indiana

Inspection
Jan 27 – Feb 5, 2003
Pages
7

In short: On February 5, 2003, FDA sent a warning letter to Roche Diagnostics GmbH in Indianapolis, Indiana.

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 Roche Diagnostics GmbH inspected by FDA?

The inspection ran Jan 27 – Feb 5, 2003, and the Warning letter is dated February 5, 2003.

How do I get the full Warning letter for Roche Diagnostics GmbH?

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