Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2010-09-29.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Sep 2010 | Not recorded | 483 | View 483 → |
| 9 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2010
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Kelly D Moore, Bryan J Love
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.225 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.265(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.170(b) | 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(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 1271.250(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(d) | 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 |
| 21 CFR 1271.55(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ocular Systems, Inc.'s 2 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