Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-07.
At a glance
Inspections
10
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 7 Feb 2025 | Human Drugs | 483 | View 483 → |
| 12 Dec 2022 – 21 Dec 2022 | Human Drugs | Clean | |
| 31 May 2017 – 8 Jun 2017 | Human Drugs | Clean | |
| 3 Apr 2017 – 13 Apr 2017 | Human Drugs | 483 | View 483 → |
| 19 Jul 2016 – 22 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2014 – 19 Jun 2014 | Human Drugs | Clean | |
| 10 Apr 2014 – 15 Apr 2014 | Human Drugs | Clean | |
| 3 Apr 2012 | Not recorded | Clean | |
| 28 Sep 2009 | Not recorded | Clean | |
| 11 Dec 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2025
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(1)(ii)
Failure to investigate serious, unexpected events
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(2)(ii)(B)
Late submission of an ICSR
Cited by Tyanna N Hadley, Mayar M Mussa
Investigators
FDA investigators tied to this site in the record.
Michael Serrano3 insp.
Tyanna N Hadley2 insp.
Shirley S Wen2 insp.
Mayar M Mussa1 insp.
Nina Yang1 insp.
Meredith L Sheridan1 insp.
Peter R Lenahan1 insp.
Justine Tomasso1 insp.
Loretta Nemchik1 insp.
Dorothy J Denes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novo Nordisk Inc.'s 3 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