Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-23.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Apr 2026 | Biologics | Clean | |
| 17 May 2023 – 19 May 2023 | Biologics | Clean | |
| 11 Mar 2019 – 14 Mar 2019 | Biologics | 483 | View 483 → |
| 29 Sep 2016 – 14 Oct 2016 | Biologics | 483 | View 483 → |
| 20 Oct 2010 | Not recorded | 483 | View 483 → |
| 9 Aug 2005 | Not recorded | Clean | |
| 19 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Oct 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Ivan E Reyes, Colleen M Aspinwall
14 Oct 2016
21 CFR 606.65(e)
Following manufacturer's instructions
Cited by Ivan E Reyes, Colleen M Aspinwall
14 Oct 2016
21 CFR 630.10(e)(2)
Additional Medical Assessment Factors
Cited by Ivan E Reyes, Colleen M Aspinwall
Investigators
FDA investigators tied to this site in the record.
Mizanne E Lewis1 insp.
Sergio E Delgado1 insp.
Laura E Garcia1 insp.
Ivan E Reyes1 insp.
Colleen M Aspinwall1 insp.
Gabriel E Muniz1 insp.
Heather M Bullock1 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 | 2x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.5(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.52 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grifols Bio Supplies Inc's 3 Form 483s
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