Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-07-03.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jun 2018 – 3 Jul 2018 | Human Drugs | WL | View 483 → |
| 19 Feb 2013 – 4 Mar 2013 | Human Drugs | Clean | |
| 25 Feb 2011 | Not recorded | 483 | On file |
| 13 Oct 2009 | Not recorded | 483 | View 483 → |
| 20 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jul 2018
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by David A Oluwo, Jonathan W Chapman
3 Jul 2018
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by David A Oluwo, Jonathan W Chapman
3 Jul 2018
21 CFR 211.166(b)
Adequate number of batches on stability
Cited by David A Oluwo, Jonathan W Chapman
3 Jul 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Jonathan W Chapman
Investigators
FDA investigators tied to this site in the record.
Rachel C Harrington2 insp.
Monique-Rac Lester2 insp.
David A Oluwo1 insp.
Jonathan W Chapman1 insp.
Nebil A Oumer1 insp.
Ernest Bizjak1 insp.
Stephanie L Shapley1 insp.
William H Linkroum1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(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 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Izeen Pharma Inc's 4 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