Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-04-10.
At a glance
Inspections
10
Form 483s
4
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Apr 2017 – 10 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Dec 2015 – 5 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jun 2013 – 14 Jun 2013 | Medical Devices & Rad Health | 483 | On file |
| 6 Mar 2012 | Not recorded | 483 | On file |
| 25 May 2007 | Not recorded | Clean | |
| 17 Dec 2005 | Not recorded | Clean | |
| 24 Mar 2005 | Not recorded | Clean | |
| 17 Mar 2005 | Not recorded | Clean | |
| 30 Apr 2004 | Not recorded | Clean | |
| 12 Aug 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Apr 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Melanie W Pishnery, Samuel L Murray, Sayeeda Hdabe
10 Apr 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Melanie W Pishnery, Samuel L Murray, Sayeeda Hdabe
10 Apr 2017
21 CFR 820.50(a)(2)
Supplier oversight
Cited by Melanie W Pishnery, Samuel L Murray, Sayeeda Hdabe
10 Apr 2017
21 CFR 820.50(a)(2)
Supplier oversight
Cited by Melanie W Pishnery, Samuel L Murray, Sayeeda Hdabe
5 Jan 2016
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
Investigators
FDA investigators tied to this site in the record.
Miaja Umaedi3 insp.
Samuel L Murray2 insp.
Sayeeda Hdabe2 insp.
Claudette D Brooks2 insp.
Melanie W Pishnery1 insp.
Dawn M Braswell1 insp.
Sean T Creighton1 insp.
Trang N Cox1 insp.
Paul W Moy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind bioMerieux, Inc.'s 4 Form 483s
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