Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 19 Sep 2025 | Biologics | 483 | View 483 → |
| 21 Aug 2019 | Human Drugs | Clean | |
| 5 Sep 2017 – 7 Sep 2017 | Human Drugs | 483 | View 483 → |
| 3 Nov 2014 – 6 Nov 2014 | Human Drugs | 483 | View 483 → |
| 15 Sep 2011 | Not recorded | 483 | On file |
| 6 Feb 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Sep 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Priscilla M Pastrana, Richard L Bartlett
19 Sep 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Priscilla M Pastrana, Richard L Bartlett
19 Sep 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Priscilla M Pastrana, Richard L Bartlett
19 Sep 2025
21 CFR 211.42(c)(9)
Control / Lab Operations Area
Cited by Priscilla M Pastrana, Richard L Bartlett
7 Sep 2017
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Helen B Ricalde
Investigators
FDA investigators tied to this site in the record.
Priscilla M Pastrana1 insp.
Richard L Bartlett1 insp.
MRA DavisM1 insp.
Helen B Ricalde1 insp.
Timothy T Kapsala1 insp.
Chad N Thompson1 insp.
Patricia F Hughes Troost1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eurofins PROXY Laboratories B.V.'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