Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-07.
At a glance
Inspections
14
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2019 – 7 Nov 2019 | Human Drugs | 483 | View 483 → |
| 22 Jan 2019 – 24 Jan 2019 | Human Drugs | Clean | |
| 3 Oct 2017 – 10 Oct 2017 | Human Drugs | Clean | |
| 16 Nov 2015 – 20 Nov 2015 | Human Drugs | 483 | On file |
| 25 Sep 2012 | Not recorded | 483 | On file |
| 25 Aug 2011 | Not recorded | 483 | View 483 → |
| 30 Apr 2010 | Not recorded | 483 | View 483 → |
| 16 Jun 2008 | Not recorded | Clean | |
| 7 Mar 2006 | Not recorded | Clean | |
| 27 Aug 2003 | Not recorded | Clean | |
| 23 May 2002 | Not recorded | Clean | |
| 13 Feb 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2011
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
Investigators
FDA investigators tied to this site in the record.
Erika V Butler2 insp.
Zachary A Bogorad2 insp.
Nayan J Patel2 insp.
Matthew R Dionne2 insp.
Michael A Charles1 insp.
Bryce A Hammer1 insp.
Kimberley A Hoefen1 insp.
Matthew J Hansen1 insp.
Linda M Cherry1 insp.
Anthony J Lagreca1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 5 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