Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Mar 2026 – 9 Apr 2026 | Biologics | Clean | |
| 2 Mar 2026 – 3 Mar 2026 | Biologics | Clean | |
| 19 Dec 2022 | Biologics | Clean | |
| 16 Jan 2013 | Not recorded | 483 | View 483 → |
| 3 Sep 2009 | Not recorded | 483 | View 483 → |
| 6 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Ashley Segura
3 Sep 2009
21 CFR 820.198(a)(3)
Processing MDRs {see also 803, 804}
Cited by Kimberly Lewandowski-Walker
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bioresource Technology Inc's 2 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