Overview
- 17 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
17
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2026 – 5 Feb 2026 | Biologics | 483 | View 483 → |
| 28 Aug 2023 – 1 Sep 2023 | Biologics | 483 | On file |
| 28 Apr 2022 – 6 May 2022 | Biologics | 483 | On file |
| 5 Dec 2018 – 13 Dec 2018 | Biologics | 483 | On file |
| 6 Feb 2017 – 10 Feb 2017 | Biologics | 483 | On file |
| 12 Oct 2016 – 21 Oct 2016 | Biologics | 483 | On file |
| 18 Mar 2014 – 1 Apr 2014 | Biologics | 483 | On file |
| 13 Jan 2011 | Not recorded | 483 | On file |
| 14 May 2010 | Not recorded | 483 | On file |
| 5 Jun 2009 | Not recorded | Clean | |
| 24 Apr 2009 | Not recorded | 483 | On file |
| 26 Jan 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Vijaya L Simhadri, Jennifer L Reed, Brentley S Pittman, Katarzyna I Jankowska
5 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Vijaya L Simhadri, Jennifer L Reed, Brentley S Pittman, Katarzyna I Jankowska
5 Feb 2026
21 CFR 600.80(c)(1)(i)
Reporting Requirements - 15-day alert
Cited by Vijaya L Simhadri, Jennifer L Reed, Brentley S Pittman, Katarzyna I Jankowska
Investigators
FDA investigators tied to this site in the record.
Mihaly S Ligmond3 insp.
Bradley J Dworak2 insp.
Gene D Arcy2 insp.
Vijaya L Simhadri1 insp.
Jennifer L Reed1 insp.
Brentley S Pittman1 insp.
Katarzyna I Jankowska1 insp.
Yonggang Wang1 insp.
Kula N Jha1 insp.
Susan M Jackson1 insp.
Laurel A Beer1 insp.
Cynthia Jim1 insp.
Richard H Coats1 insp.
Wei Wang1 insp.
Prabhu P Raju1 insp.
Christian Lynch1 insp.
Donald B Ertel1 insp.
Sean R Byrd1 insp.
Daniel C Kearns1 insp.
Helen B Ricalde1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grifols Therapeutics LLC's 10 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