Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2010-12-03.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Dec 2010 | Not recorded | 483 | View 483 → |
| 23 Dec 2009 | Not recorded | Clean | |
| 17 Sep 2008 | Not recorded | 483 | On file |
| 6 Dec 2002 | Not recorded | Clean | |
| 24 Jan 2002 | Not recorded | Clean | |
| 30 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Dec 2010
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Dell S Moller
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 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boehringer Ingelheim Roxane Inc's 2 Form 483s
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