Overview
- 11 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-18.
At a glance
Inspections
11
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2022 – 18 Nov 2022 | Human Drugs | 483 | View 483 → |
| 16 Sep 2019 – 20 Sep 2019 | Human Drugs | 483 | On file |
| 23 Oct 2017 – 27 Oct 2017 | Human Drugs | 483 | View 483 → |
| 3 Nov 2014 – 7 Nov 2014 | Human Drugs | 483 | View 483 → |
| 4 Feb 2013 | Not recorded | 483 | On file |
| 21 Dec 2012 | Not recorded | 483 | View 483 → |
| 7 Nov 2011 | Not recorded | 483 | View 483 → |
| 29 Oct 2010 | Not recorded | 483 | View 483 → |
| 26 Mar 2009 | Not recorded | 483 | View 483 → |
| 5 Mar 2008 | Not recorded | 483 | On file |
| 27 Oct 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Nov 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Brent M Dehaan, Joseph A Piechocki, Amanda M Dunneback
18 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Brent M Dehaan, Joseph A Piechocki, Amanda M Dunneback
18 Nov 2022
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Brent M Dehaan, Joseph A Piechocki, Amanda M Dunneback
27 Oct 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Matthew B Casale, Charles L Zhou, Caroline Strasinger
27 Oct 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Matthew B Casale, Charles L Zhou, Caroline Strasinger
Investigators
FDA investigators tied to this site in the record.
Martha Sullivan Myrick4 insp.
Charles L Zhou2 insp.
Jeffrey D Meng2 insp.
Constantin Y Philopoulos2 insp.
Brent M Dehaan1 insp.
Joseph A Piechocki1 insp.
Amanda M Dunneback1 insp.
Matthew B Casale1 insp.
Caroline Strasinger1 insp.
Rebecca E Dombrowski1 insp.
Sneha S Patel1 insp.
Patsy J Domingo1 insp.
Sanket N Patel1 insp.
Adam J Wilson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Corium Innovations, Inc.'s 10 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