Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-19.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2019 – 19 Sep 2019 | Human Drugs | 483 | On file |
| 9 Sep 2019 – 10 Sep 2019 | Human Drugs | Clean | |
| 14 Sep 2017 – 22 Sep 2017 | Human Drugs | 483 | On file |
| 28 May 2015 – 5 Jun 2015 | Human Drugs | 483 | View 483 → |
| 13 Jun 2013 – 21 Jun 2013 | Human Drugs | 483 | On file |
| 27 Sep 2011 | Not recorded | 483 | On file |
| 23 Oct 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen1 insp.
Francis A Guidry1 insp.
Santos E Camara1 insp.
April L Young1 insp.
Debra M Emerson1 insp.
Christian Lynch1 insp.
Caryn M Mcnab1 insp.
Steven A Gonzales1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AstraZeneca Nijmegen B.V.'s 6 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