Dragon Heart Medical Inc
Form 483 issued May 31, 2019 · Addison, Illinois
- Inspection
- Apr 24 – May 31, 2019
- Investigator
- Brittani N. Franklin
- Observations
- 1
- Pages
- 9
- FEI number
- 3004735647
In short: On May 31, 2019, FDA issued a Form 483 with 1 observation to Dragon Heart Medical Inc in Addison, Illinois (FEI 3004735647) after an inspection that ran Apr 24 – May 31, 2019. The investigator was Brittani N. Franklin. 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(a) (1×) · 21 CFR 803 (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.198(a)21 CFR 803
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
This inspection in context
Brittani N. Franklin
5 documents · 2016–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) 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 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?
Brittani N. Franklin is named on this Form 483, for the inspection of Apr 24 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Dragon Heart Medical Inc inspected by FDA?
The inspection ran Apr 24 – May 31, 2019, and the Form 483 is dated May 31, 2019.
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.