Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2014-03-21.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2014 – 21 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jul 2012 | Not recorded | Clean | |
| 6 Apr 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2014
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Stanley B Eugene
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dravon Medical, Inc.'s 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat