Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-05.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2024 – 5 Apr 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Aug 2021 – 5 Aug 2021 | Medical Devices & Rad Health | Clean | |
| 15 May 2018 | Medical Devices & Rad Health | Clean | |
| 16 Oct 2017 – 23 Oct 2017 | Medical Devices & Rad Health | 483 | On file |
| 23 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 14 Mar 2016 – 18 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 18 Oct 2012 | Not recorded | Clean | |
| 5 Aug 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
MDSAP harperd2 insp.
James R Montero1 insp.
Daniel J Lahar1 insp.
MDSAP WilliamsA1 insp.
Justin H Erickson1 insp.
Marc A Jackson1 insp.
Janet Pulver1 insp.
Kimetha A King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BioFire Diagnostics, LLC's 3 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