Merge Healthcare, Inc
Form 483 issued July 27, 2015 · Hartland, Wisconsin
- Inspection
- Jun 3 – Jul 27, 2015
- Investigator
- Richard J. Tucker
- Observations
- 7
- Pages
- 6
- FEI number
- 1000116130
In short: On July 27, 2015, FDA issued a Form 483 with 7 observations to Merge Healthcare, Inc in Hartland, Wisconsin (FEI 1000116130) after an inspection that ran Jun 3 – Jul 27, 2015. The investigator was Richard J. Tucker. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
5 of 7 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (2×) · 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 03
Complaints invoking the possible failure of a de\ice and labeling to meet any of its specifications…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Richard J. Tucker
2 documents · 2015–2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Wisconsin.
The firmMerge Healthcare, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merge Healthcare, Inc?
FDA listed 7 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Merge Healthcare, Inc?
Richard J. Tucker is named on this Form 483, for the inspection of Jun 3 – Jul 27, 2015. Each investigator has a profile showing what they cite most.
When was Merge Healthcare, Inc inspected by FDA?
The inspection ran Jun 3 – Jul 27, 2015, and the Form 483 is dated July 27, 2015.
How do I get the full Form 483 for Merge Healthcare, 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.