Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-20.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Aug 2019 – 20 Aug 2019 | Medical Devices & Rad Health | WL | View 483 → |
| 17 Jan 2017 – 25 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jun 2015 – 9 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2014 – 30 Jul 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 5 Feb 2013 | Not recorded | 483 | View 483 → |
| 14 Nov 2011 | Not recorded | Clean | |
| 11 Dec 2009 | Not recorded | Clean | |
| 7 May 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Aug 2019
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Joseph D Gong, Christina L Bigham
20 Aug 2019
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Joseph D Gong, Christina L Bigham
20 Aug 2019
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Joseph D Gong, Christina L Bigham
20 Aug 2019
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Joseph D Gong, Christina L Bigham
20 Aug 2019
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Joseph D Gong, Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Eric M Padgett5 insp.
Edward E Lockwood3 insp.
James D Planchon2 insp.
Kelly D Sheppard2 insp.
Joseph D Gong1 insp.
Christina L Bigham1 insp.
Shafiq Ahadi1 insp.
Sean T Creighton1 insp.
Steven D Kehoe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomerieux Inc's 5 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