Overview
- 16 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-26.
At a glance
Inspections
16
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Aug 2025 – 26 Aug 2025 | Biologics | 483 | View 483 → |
| 24 Jun 2024 – 28 Jun 2024 | Biologics | 483 | On file |
| 2 Apr 2023 – 3 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 9 Feb 2022 – 17 Feb 2022 | Biologics | 483 | View 483 → |
| 10 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 9 Nov 2017 | Biologics | Clean | |
| 28 Jun 2016 – 30 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 18 Jan 2016 | Biologics | 483 | On file |
| 3 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 20 May 2013 | Biologics | Clean | |
| 25 Jan 2013 | Not recorded | Clean | |
| 19 Aug 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Feb 2022
21 CFR 820.198(d)
Evaluation, timeliness, identification
Cited by Gene D Arcy, Linda Thai, Lauren M Lilly
17 Feb 2022
21 CFR 820.198(d)
Evaluation, timeliness, identification
Cited by Gene D Arcy, Linda Thai, Lauren M Lilly
17 Feb 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Gene D Arcy, Linda Thai, Lauren M Lilly
17 Feb 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Gene D Arcy, Linda Thai, Lauren M Lilly
Investigators
FDA investigators tied to this site in the record.
Leonard H Lavi3 insp.
Gene D Arcy2 insp.
Prabhu P Raju2 insp.
Omotunde O Osunsanmi2 insp.
Creighton T Tuzon1 insp.
Bradley J Dworak1 insp.
Zhugong Liu1 insp.
Antonia L Panthiruvelil1 insp.
Emilia A Sippert1 insp.
State Agency1 insp.
Linda Thai1 insp.
Lauren M Lilly1 insp.
James A Lane1 insp.
Guang Gao1 insp.
Uros V Djekic1 insp.
Ademola O Daramola1 insp.
Christian Lynch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grifols Diagnostic Solutions, INC.'s 6 Form 483s
Source PDFs 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