HeartWare Inc.

Warning letter issued June 2, 2014 · Framingham, Massachusetts

Inspection: Jan 13 – Jan 24, 2014
Pages: 4
FEI number: 3007042319

In short: On June 2, 2014, FDA sent a warning letter to HeartWare Inc. in Framingham, Massachusetts (FEI 3007042319).

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

The firm

HeartWare Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Questions about this warning letter

When was HeartWare Inc. inspected by FDA?

The inspection ran Jan 13 – Jan 24, 2014, and the Warning letter is dated June 2, 2014.

How do I get the full Warning letter for HeartWare Inc.?

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.