Dragon Heart Medical Inc
FDA inspection history in Addison, Illinois, 2018 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Addison, Illinois.
- 2018The longest 483 on file: 4 observations over 5 pages at Addison, Illinois.
Cited most
Across all Dragon Heart Medical observations on file
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 8031
- 21 CFR 820.181Device master record1
- 21 CFR 820.40(a)Document controls1
- 21 CFR 820.50Purchasing controls1
The complete Dragon Heart Medical file.
All 2 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
Addison, Illinois
Two Form 483s · 2018 to 2019 · 5 observations
Latest: Form 483, May 31, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-05-31 | 483 Form 483 | Addison, Illinois | 1 | $99 |
| 2018-04-24 | 483 Form 483 | Addison, Illinois | 4 | $99 |
Investigators on these documents
FEI number 3004735647 · most recent document May 31, 2019
About Dragon Heart Medical Inc
How many FDA Form 483s has Dragon Heart Medical Inc received?
FDA Intel has 2 Form 483s on file for Dragon Heart Medical Inc; the most recent is dated May 31, 2019.
When was Dragon Heart Medical Inc last inspected by FDA?
The most recent FDA inspection document on file for Dragon Heart Medical Inc is a Form 483 dated May 31, 2019, for the site in Addison, Illinois.
What did FDA cite at Dragon Heart Medical Inc?
The regulations cited most in the observations on file for Dragon Heart Medical Inc are 21 CFR 820.198(a) (Complaint files), 2 times; 21 CFR 803, 1 time; 21 CFR 820.181 (Device master record), 1 time.