Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-09.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2025 – 9 Dec 2025 | Biologics | 483 | View 483 → |
| 30 Oct 2023 – 7 Nov 2023 | Biologics | 483 | View 483 → |
| 1 Jul 2022 – 8 Jul 2022 | Biologics | Clean | |
| 25 Feb 2019 – 1 Mar 2019 | Biologics | 483 | On file |
| 1 Mar 2019 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Dec 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Peng Zhou, Thai D Truong
Investigators
FDA investigators tied to this site in the record.
Pankaj H Amin2 insp.
Anissa M Cheung2 insp.
Peng Zhou1 insp.
Thai D Truong1 insp.
Lewis K Antwi1 insp.
Unnee Ranjan1 insp.
Susan M Jackson1 insp.
Viviana Matta1 insp.
Hector A Carrero1 insp.
Erin C Hill1 insp.
Viviana R Ramirez1 insp.
Bharat Khurana1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bavarian Nordic A/S' 3 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