Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-07-17.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2020 – 17 Jul 2020 | Medical Devices & Rad Health | 483 | On file |
| 14 Aug 2017 – 16 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2014 – 27 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2014
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Erin M Miller, Bleta Vuniqi, Tracey L Siebesma
27 Feb 2014
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Erin M Miller, Bleta Vuniqi, Tracey L Siebesma
Investigators
FDA investigators tied to this site in the record.
MDSAP harperd1 insp.
Cynthia L Aycock1 insp.
Erin M Miller1 insp.
Bleta Vuniqi1 insp.
Tracey L Siebesma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ranir, 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