Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2025 – 9 May 2025 | Biologics | Clean | |
| 10 Dec 2018 – 14 Dec 2018 | Biologics | Clean | |
| 17 Jul 2017 – 20 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 13 Feb 2017 – 16 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2016 – 14 Nov 2016 | Biologics | 483 | On file |
| 22 Jan 2015 – 30 Jan 2015 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Feb 2017
21 CFR 820.50(a)(1)
Evaluation and Selection, Suppliers, Contractors, etc.
Cited by Roy Baby
Investigators
FDA investigators tied to this site in the record.
Meihong Liu2 insp.
Celeta S Coves1 insp.
Kaarin M Slotte1 insp.
Silvia M Blackshire1 insp.
Gene D Arcy1 insp.
Sharmila Shrestha1 insp.
MDSAP harperd1 insp.
Roy Baby1 insp.
Simone E Pitts1 insp.
Cynthia Jim1 insp.
Mihaly S Ligmond1 insp.
Joyce A Rockwell1 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 | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Diagnostic Grifols, S.A.'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