Merge Healthcare, Inc
FDA inspection history across 2 sites, 2015 to 2016
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2015: one warning letter and one Form 483; 2016: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16One warning letter, one Form 483 and one close-out letter, at Chicago, Illinois and Hartland, Wisconsin.
Cited most
Across all Merge Healthcare observations on file
- 21 CFR 820.198Complaint files2
- 21 CFR 820.30Design controls2
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 806.10Reports of corrections and removals1
- 21 CFR 820.90Nonconforming product1
The complete Merge Healthcare file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chicago, Illinois
One close-out letter and one warning letter · 2015 to 2016
Latest: Close-out, Sep 27, 2016 →Hartland, Wisconsin
One Form 483 · 2015 · 7 observations
Latest: Form 483, Jul 27, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-09-27 | Close-out Close-out letter | Chicago, Illinois | — | $99 |
| 2015-09-30 | Warning letter Warning letter | Chicago, Illinois | — | $99 |
| 2015-07-27 | 483 Form 483 | Hartland, Wisconsin | 7 | $99 |
Investigators on these documents
FEI number 1000116130 · most recent document Sep 27, 2016
About Merge Healthcare, Inc
How many FDA Form 483s has Merge Healthcare, Inc received?
FDA Intel has 1 Form 483 on file for Merge Healthcare, Inc; the most recent is dated Jul 27, 2015.
When was Merge Healthcare, Inc last inspected by FDA?
The most recent FDA inspection document on file for Merge Healthcare, Inc is a Form 483 dated Jul 27, 2015, for the site in Hartland, Wisconsin.
What did FDA cite at Merge Healthcare, Inc?
The regulations cited most in the observations on file for Merge Healthcare, Inc are 21 CFR 820.198 (Complaint files), 2 times; 21 CFR 820.30 (Design controls), 2 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time.
Has Merge Healthcare, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Merge Healthcare, Inc; the most recent is dated Sep 30, 2015.