Overview
- 13 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-05.
At a glance
Inspections
13
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2024 – 5 Mar 2024 | Biologics | Clean | |
| 9 Nov 2023 – 17 Nov 2023 | Biologics | 483 | View 483 → |
| 17 Jun 2019 – 25 Jun 2019 | Biologics | 483 | On file |
| 13 Mar 2017 – 24 Mar 2017 | Biologics | 483 | On file |
| 4 Sep 2015 – 16 Sep 2015 | Biologics | 483 | On file |
| 10 Jul 2013 – 18 Jul 2013 | Biologics | 483 | On file |
| 22 Mar 2011 | Not recorded | 483 | On file |
| 7 May 2009 | Not recorded | 483 | On file |
| 3 May 2007 | Not recorded | Clean | |
| 15 Jun 2004 | Not recorded | Clean | |
| 24 Sep 2002 | Not recorded | Clean | |
| 11 Jan 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Nov 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Shafiq Ahadi, Susan M Jackson, Natalya M Ananyeva, Sergey S Akimov
17 Nov 2023
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Shafiq Ahadi, Susan M Jackson, Natalya M Ananyeva, Sergey S Akimov
17 Nov 2023
21 CFR 211.166(a)
Written program not followed
Cited by Shafiq Ahadi, Susan M Jackson, Natalya M Ananyeva, Sergey S Akimov
17 Nov 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Shafiq Ahadi, Susan M Jackson, Natalya M Ananyeva, Sergey S Akimov
17 Nov 2023
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Shafiq Ahadi, Susan M Jackson, Natalya M Ananyeva, Sergey S Akimov
Investigators
FDA investigators tied to this site in the record.
Natalya M Ananyeva2 insp.
Omotunde O Osunsanmi2 insp.
Xiuju Lu1 insp.
Grace I Cortesini1 insp.
Shafiq Ahadi1 insp.
Susan M Jackson1 insp.
Sergey S Akimov1 insp.
Gene D Arcy1 insp.
Cynthia Jim1 insp.
Christine Harman1 insp.
Simone E Pitts1 insp.
Helen B Ricalde1 insp.
Burnell M Henry1 insp.
Prabhu P Raju1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Instituto Grifols, S.A.'s 7 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