Dragon Heart Medical Inc.
Form 483 issued April 24, 2018 · Addison, Illinois
- Inspection
- Apr 3 – Apr 24, 2018
- Investigator
- Amanda Dinaro
- Observations
- 1
- Pages
- 5
In short: On April 24, 2018, FDA issued a Form 483 with 1 observation to Dragon Heart Medical Inc. in Addison, Illinois after an inspection that ran Apr 3 – Apr 24, 2018. The investigator was Amanda Dinaro. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
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
The site's inspection history, in date order.
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 Dragon Heart Medical Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). 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.