Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jul 2024 – 26 Jul 2024 | Biologics | 483 | View 483 → |
| 17 Sep 2019 – 20 Sep 2019 | Human Drugs | Clean | |
| 31 Aug 2017 – 8 Sep 2017 | Human Drugs | 483 | On file |
| 14 May 2015 – 21 May 2015 | Human Drugs | Clean | |
| 11 Jul 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2024
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Irina Gaberman
Investigators
FDA investigators tied to this site in the record.
Irina Gaberman1 insp.
MRA DavisM1 insp.
Kellia N Hicks1 insp.
Christophe T Peters1 insp.
Lucas B Leake1 insp.
Simone E Pitts1 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 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Laboratorios Grifols, S.A.'s 3 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