Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
5 Jan 2010
21 CFR 1271.200(d)
Inspected routinely
Cited by Susan M Miller, Denise L Burosh, Melissa J Holz
5 Jan 2010
21 CFR 1271.200(e)
Documentation of maintenance and cleaning
Cited by Susan M Miller, Denise L Burosh, Melissa J Holz
Inspected site
GLGreat Lakes Orthopedics, LLCBrookfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 1271.200(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere