Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2014-02-25.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2014 – 25 Feb 2014 | Human Drugs | Clean | |
| 28 Jun 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jun 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Matthew J Hansen, Ginger M Sykes
28 Jun 2011
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Matthew J Hansen, Ginger M Sykes
28 Jun 2011
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Matthew J Hansen, Ginger M Sykes
28 Jun 2011
21 CFR 211.204
Returned drug procedures in writing and followed
Cited by Matthew J Hansen, Ginger M Sykes
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 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quadex Pharmaceuticals, Llc's 1 Form 483
Source PDFs, 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