Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-08-25.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Aug 2015 – 25 Aug 2015 | Medical Devices & Rad Health | Clean | |
| 3 Apr 2013 – 17 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 9 Mar 2010 | Not recorded | 483 | View 483 → |
| 18 Apr 2008 | Not recorded | 483 | On file |
| 28 Feb 2007 | Not recorded | Clean | |
| 6 Dec 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Mar 2010
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Pamela A Kuist
9 Mar 2010
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Pamela A Kuist
9 Mar 2010
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Pamela A Kuist
Investigators
FDA investigators tied to this site in the record.
Maribeth G Niesen1 insp.
Javonica F Penn1 insp.
Pamela A Kuist1 insp.
Troy A Huffman1 insp.
Lauren R Collins1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olsen Medical's 3 Form 483s
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