Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
11
Form 483s
4
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2025 – 13 Jun 2025 | Human Drugs | Clean | |
| 6 Jul 2023 – 13 Jul 2023 | Human Drugs | 483 | On file |
| 9 May 2022 – 13 May 2022 | Human Drugs | 483 | On file |
| 7 Feb 2022 – 10 Feb 2022 | Human Drugs | Clean | |
| 8 Jan 2018 – 12 Jan 2018 | Human Drugs | Clean | |
| 18 Aug 2014 – 21 Aug 2014 | Human Drugs | Clean | |
| 16 Aug 2012 | Not recorded | Clean | |
| 1 Jul 2011 | Not recorded | Clean | |
| 3 Sep 2010 | Not recorded | Clean | |
| 2 Sep 2009 | Not recorded | 483 | View 483 → |
| 26 Sep 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sharon K Thoma, Hai Lien T Phung
2 Sep 2009
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Sharon K Thoma, Hai Lien T Phung
2 Sep 2009
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Sharon K Thoma, Hai Lien T Phung
2 Sep 2009
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Sharon K Thoma, Hai Lien T Phung
2 Sep 2009
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Sharon K Thoma, Hai Lien T Phung
Investigators
FDA investigators tied to this site in the record.
Annet R Rajan1 insp.
Janet A Rajan1 insp.
Tanya R Syffrard1 insp.
Seneca D Toms1 insp.
Brittny C Cargo1 insp.
Santos E Camara1 insp.
Luis A Carrion1 insp.
Adam R Cooke1 insp.
Viviana Matta1 insp.
Daveta L Bailey1 insp.
Marvin D Jones1 insp.
Penny H Mccarver1 insp.
Jason F Chancey1 insp.
Sharon K Thoma1 insp.
Hai Lien T Phung1 insp.
Robert D Tollefsen1 insp.
Thomas R Berry1 insp.
Ibad U Khan1 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 | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novo Nordisk Pharmaceutical Industries LP'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