Overview
- 23 public-safe observations are available for this inspection.
- 22 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Sep 2009
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Linda M Cherry, Marc A Jackson
9 Sep 2009
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Linda M Cherry, Marc A Jackson
9 Sep 2009
21 CFR 1271.190(c)
Separate or defined operational areas
Cited by Linda M Cherry, Marc A Jackson
Inspected site
OSOcular Systems, Inc.Aurora, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.190(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.225 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.350(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 23 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