Dragon Heart Medical Inc
Form 483 issued April 24, 2018 · Addison, Illinois
- Inspection
- Apr 3 – Apr 24, 2018
- Investigator
- Amanda Dinaro
- Observations
- 4
- Pages
- 5
- FEI number
- 3004735647
In short: On April 24, 2018, FDA issued a Form 483 with 4 observations to Dragon Heart Medical Inc in Addison, Illinois (FEI 3004735647) after an inspection that ran Apr 3 – Apr 24, 2018. The investigator was Amanda Dinaro. Most observations concern records & documents and cAPA.
At a glance
Records & documents and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
A device master record…
- 04
Documents were not available at all locations for which they are designated…
This inspection in context
Amanda Dinaro
7 documents · 2017–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Illinois.
The firmDragon Heart Medical 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 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dragon Heart Medical Inc?
FDA listed 4 observations on this Form 483, mostly about records & documents, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Dragon Heart Medical Inc?
Amanda Dinaro is named on this Form 483, for the inspection of Apr 3 – Apr 24, 2018. Each investigator has a profile showing what they cite most.
When was Dragon Heart Medical Inc inspected by FDA?
The inspection ran Apr 3 – Apr 24, 2018, and the Form 483 is dated April 24, 2018.
How do I get the full Form 483 for Dragon Heart Medical 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.