Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-29.
At a glance
Inspections
6
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2024 – 29 Mar 2024 | Biologics | 483 | View 483 → |
| 8 Nov 2021 – 13 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Sep 2016 – 23 Sep 2016 | Human Drugs | 483 | View 483 → |
| 18 Aug 2014 – 21 Aug 2014 | Human Drugs | Clean | |
| 24 May 2012 | Not recorded | 483 | On file |
| 13 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Mar 2024
21 CFR 58.130(c)
Conduct: identification of test specimens
Cited by Dina A Tallman, Chelsea W Lamm
29 Mar 2024
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Dina A Tallman, Chelsea W Lamm
13 Nov 2021
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Andrea A Branche, Kellie L Thommes
13 Nov 2021
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Andrea A Branche, Kellie L Thommes
13 Nov 2021
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Andrea A Branche, Kellie L Thommes
Investigators
FDA investigators tied to this site in the record.
Nancy A Bellamy2 insp.
Dina A Tallman1 insp.
Chelsea W Lamm1 insp.
Andrea A Branche1 insp.
Kellie L Thommes1 insp.
Natalie A Mickelsen1 insp.
Joseph R Haynes1 insp.
William D Tingley1 insp.
Anthony R Petriella1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 58.45 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.90(h) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.63(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Northern Biomedical Research, Inc.'s 5 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