Heartware, Inc.
Form 483 issued July 31, 2015 · Framingham, Massachusetts
- Inspection
- Jul 16 – Jul 31, 2015
- Investigator
- Tamara S. Rosbury
- Observations
- 6
- Pages
- 10
- FEI number
- 3010767211
In short: On July 31, 2015, FDA issued a Form 483 with 6 observations to Heartware, Inc. in Framingham, Massachusetts (FEI 3010767211) after an inspection that ran Jul 16 – Jul 31, 2015. The investigator was Tamara S. Rosbury. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 4 of 6 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design validation have…
- 03
Procedures for design change have…
- 04
Risk analysis is inadequate…
This inspection in context
Tamara S. Rosbury
1 document · 2015
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmHeartware, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Heartware, Inc.?
FDA listed 6 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Heartware, Inc.?
Tamara S. Rosbury is named on this Form 483, for the inspection of Jul 16 – Jul 31, 2015. Each investigator has a profile showing what they cite most.
When was Heartware, Inc. inspected by FDA?
The inspection ran Jul 16 – Jul 31, 2015, and the Form 483 is dated July 31, 2015.
How do I get the full Form 483 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.