Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-05.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jul 2022 – 5 Aug 2022 | Human Drugs | WL | View 483 → |
| 25 Mar 2019 – 9 Apr 2019 | Human Drugs | 483 | On file |
| 30 May 2017 – 10 Jul 2017 | Human Drugs | Clean | |
| 27 Aug 2015 – 30 Sep 2015 | Human Drugs | 483 | View 483 → |
| 1 Jul 2014 – 2 Jul 2014 | Human Drugs | Clean | |
| 5 Aug 2013 – 19 Aug 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2022
FDCA 501(a)(2)(A)
Air flow quality, higher classified area
Cited by Sena G Dissmeyer, Tekalign Wondimu, Amy N Chen
5 Aug 2022
FDCA 501(a)(2)(A)
Cleanliness, ISO-classified areas
Cited by Sena G Dissmeyer, Tekalign Wondimu, Amy N Chen
5 Aug 2022
FDCA 501(a)(2)(A)
Disinfecting materials, aseptic processing area
Cited by Sena G Dissmeyer, Tekalign Wondimu, Amy N Chen
5 Aug 2022
FDCA 501(a)(2)(A)
Dust-collecting overhangs, surrounding area of ISO 5
Cited by Sena G Dissmeyer, Tekalign Wondimu, Amy N Chen
5 Aug 2022
FDCA 501(a)(2)(A)
Inadequate sporicidal agents, cleanroom and ISO 5 area
Cited by Sena G Dissmeyer, Tekalign Wondimu, Amy N Chen
Investigators
FDA investigators tied to this site in the record.
Michael R Klapal3 insp.
Jose M Cayuela2 insp.
Sena G Dissmeyer1 insp.
Tekalign Wondimu1 insp.
Amy N Chen1 insp.
Nancy F Scheraga1 insp.
Jay T Wong1 insp.
Helen Verdel1 insp.
Douglas C Kovacs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ImprimisRx NJ'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