Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-07-09.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2018 | Biologics | Clean | |
| 21 Oct 2015 – 23 Oct 2015 | Biologics | 483 | View 483 → |
| 26 Nov 2013 | Biologics | Clean | |
| 17 Oct 2011 | Not recorded | Clean | |
| 5 Jan 2010 | Not recorded | 483 | View 483 → |
| 10 Apr 2008 | Not recorded | 483 | On file |
| 15 Oct 2003 | Not recorded | Clean | |
| 30 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jan 2010
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Susan M Miller, Denise L Burosh, Melissa J Holz
5 Jan 2010
21 CFR 1271.160(c)
Quality audits performed periodically
Cited by Susan M Miller, Denise L Burosh, Melissa J Holz
Investigators
FDA investigators tied to this site in the record.
Denise L Burosh4 insp.
Susan M Miller2 insp.
Susan M North1 insp.
Melissa J Holz1 insp.
Sarah A Palmer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Great Lakes Orthopedics, LLC'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