Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-04-19.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Apr 2011 | Not recorded | 483 | View 483 → |
| 4 Nov 2010 | Not recorded | 483 | View 483 → |
| 9 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2010
21 CFR 110.80
Reasonable precautions
Cited by Ashley Segura, Stephanie C Milan, Jose N Santiago
Investigators
FDA investigators tied to this site in the record.
Stephanie C Milan2 insp.
Ashley Segura1 insp.
Jose N Santiago1 insp.
Kimberly M Hull1 insp.
Diana L Kelsch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Uniqueso, Inc.'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