Overview
- 15 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-30.
At a glance
Inspections
15
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2024 – 30 Apr 2024 | Biologics | 483 | View 483 → |
| 3 Dec 2018 – 7 Dec 2018 | Biologics | 483 | View 483 → |
| 23 Feb 2017 – 2 Mar 2017 | Biologics | 483 | On file |
| 27 Jul 2015 – 30 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2015 – 27 Mar 2015 | Biologics | 483 | On file |
| 27 Feb 2013 – 7 Mar 2013 | Biologics | 483 | On file |
| 11 Aug 2011 | Not recorded | 483 | View 483 → |
| 31 Mar 2011 | Not recorded | 483 | On file |
| 5 May 2009 | Not recorded | 483 | On file |
| 1 Mar 2007 | Not recorded | Clean | |
| 8 Feb 2007 | Not recorded | Clean | |
| 12 Nov 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Apr 2024
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
30 Apr 2024
21 CFR 820.100(b)
Documentation
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
30 Apr 2024
21 CFR 820.30(j)
Design history file
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
30 Apr 2024
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
7 Dec 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Gene D Arcy, Meihong Liu, Sharmila Shrestha
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju2 insp.
Richard T Riggie1 insp.
Creighton T Tuzon1 insp.
Elias N Paz Alonzo1 insp.
Gene D Arcy1 insp.
Meihong Liu1 insp.
Sharmila Shrestha1 insp.
Jonathan B Lewis1 insp.
Debra M Emerson1 insp.
Susan M Jackson1 insp.
Cynthia Jim1 insp.
Frank J Marciniak1 insp.
Rose M Ashley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medion Grifols Diagnostics AG's 9 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