Overview
- 14 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-12.
At a glance
Inspections
14
Form 483s
13
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jul 2024 – 12 Jul 2024 | Human Drugs | 483 | On file |
| 10 Aug 2022 – 19 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Oct 2021 – 26 Oct 2021 | Human Drugs | 483 | On file |
| 11 Jun 2019 – 19 Jun 2019 | Biologics | 483 | View 483 → |
| 7 Feb 2019 – 15 Feb 2019 | Human Drugs | 483 | On file |
| 23 Jul 2018 – 31 Jul 2018 | Medical Devices & Rad Health | 483 | On file |
| 29 Jun 2017 – 7 Jul 2017 | Biologics | 483 | On file |
| 17 Nov 2016 – 25 Nov 2016 | Human Drugs | 483 | On file |
| 21 May 2015 – 28 May 2015 | Biologics | 483 | On file |
| 5 Feb 2015 – 13 Feb 2015 | Human Drugs | 483 | On file |
| 15 Jul 2013 – 19 Jul 2013 | Biologics | 483 | On file |
| 30 Jan 2013 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Aug 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yasamin Ameri
Investigators
FDA investigators tied to this site in the record.
Mihaly S Ligmond2 insp.
Viviana Matta2 insp.
Gene D Arcy2 insp.
Hamet M Toure1 insp.
Yasamin Ameri1 insp.
Lindsey J Brown1 insp.
Jessica Hankins1 insp.
James W Whitney1 insp.
Lisa B Orr1 insp.
Youmin Wang1 insp.
Ademola O Daramola1 insp.
Susanne M Richardson1 insp.
Omotunde O Osunsanmi1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Parul M Patel1 insp.
James C Maclaughlin1 insp.
Dorothy W Lee1 insp.
Burnell M Henry1 insp.
Christian Lynch1 insp.
Paul A Bonneau1 insp.
Helen B Ricalde1 insp.
Rose M Ashley1 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 | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novo Nordisk Production Belgium SA's 13 Form 483s
Source PDFs 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