Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-03-05.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2020 – 5 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Sep 2016 – 20 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jul 2012 | Not recorded | 483 | View 483 → |
| 13 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2020
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Maura Rooney, Preston M Lee
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 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Concert Medical, LLC's 3 Form 483s
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