Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 17 Apr 2026 | Human Drugs | 483 | On file |
| 28 May 2018 – 1 Jun 2018 | Human Drugs | Clean | |
| 11 Apr 2016 – 14 Apr 2016 | Human Drugs | Clean | |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | 483 | On file |
| 8 Sep 2011 | Not recorded | 483 | View 483 → |
| 30 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Sep 2011
21 CFR 211.165(a)
Testing and release for distribution
Cited by Don H Bark, Rachel C Harrington
Investigators
FDA investigators tied to this site in the record.
Ruben C Ayala1 insp.
Alan P Kurtzberg1 insp.
Scott T Ballard1 insp.
Yumi J Hiramine1 insp.
Don H Bark1 insp.
Rachel C Harrington1 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 | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novo Nordisk A/S' 3 Form 483s
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