Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-24.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2020 – 24 Jan 2020 | Biologics | Clean | |
| 29 Aug 2017 – 31 Aug 2017 | Biologics | 483 | View 483 → |
| 8 Sep 2015 – 11 Sep 2015 | Biologics | Clean | |
| 21 Sep 2012 | Not recorded | 483 | On file |
| 28 May 2010 | Not recorded | 483 | View 483 → |
| 30 May 2008 | Not recorded | Clean | |
| 17 Aug 2007 | Not recorded | Clean | |
| 8 Mar 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Aug 2017
21 CFR 606.60(a)
Equipment observed, standardized, calibrated
Cited by La-Tasha M Gunter, Amy A Johnson, Amy C Amaro
Investigators
FDA investigators tied to this site in the record.
Charles D Boison2 insp.
La-Tasha M Gunter2 insp.
Amy A Johnson1 insp.
Amy C Amaro1 insp.
Marion W Nadeau1 insp.
Paula J Bretz1 insp.
Gerald Mierle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.64(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grifols Biomat USA Inc.'s 3 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