Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-19.
At a glance
Inspections
10
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 19 Jul 2024 | Biologics | 483 | On file |
| 7 May 2019 – 17 May 2019 | Biologics | 483 | View 483 → |
| 30 May 2017 – 9 Jun 2017 | Biologics | Clean | |
| 2 Apr 2014 – 18 Apr 2014 | Biologics | 483 | On file |
| 15 Mar 2012 | Not recorded | 483 | View 483 → |
| 28 May 2010 | Not recorded | 483 | View 483 → |
| 19 Sep 2008 | Not recorded | Clean | |
| 17 Nov 2005 | Not recorded | Clean | |
| 9 Oct 2003 | Not recorded | Clean | |
| 5 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2019
21 CFR 1271.190(d)(1)
Procedures for cleaning, sanitation
Cited by Kelly D Moore, Gloria A Milster
Investigators
FDA investigators tied to this site in the record.
Marc A Jackson4 insp.
Kaarin M Slotte1 insp.
Conor J Mccarron1 insp.
Kelly D Moore1 insp.
Gloria A Milster1 insp.
Carla R Hinz1 insp.
Jennifer A Baker1 insp.
Randy V Bong1 insp.
Linda M Cherry1 insp.
Melissa J Nucci1 insp.
Kimberly A Peterson1 insp.
Theressa B Smith1 insp.
Isabel Y Espinosa1 insp.
Hanna L Potter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.190(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.170(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(14) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eurofins Donor & Product Testing LLC's 5 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