Grifols Bio Supplies Inc — FDA Facility Profile
Grifols Bio Supplies Inc is an FDA-inspected facility (FEI 1049760) located in Miami, FL, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 23, 2026: No Action Indicated (NAI)
- Inspections on record
- 5 (1 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Oct 20, 2010
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 23, 2026 | No Action Indicated (NAI) | No citations listed |
| May 19, 2023 | No Action Indicated (NAI) | No citations listed |
| Mar 14, 2019 | Voluntary Action Indicated (VAI) | When to report (21 CFR 600.14(c)) |
| Oct 14, 2016 | Voluntary Action Indicated (VAI) | CPR certification (21 CFR 630.5(d)) Additional Medical Assessment Factors (21 CFR 630.10(e)(2)) Following manufacturer's instructions (21 CFR 606.65(e)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Oct 20, 2010 | Official Action Indicated (OAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Donor suitability determined by unqualified person (21 CFR 640.3(a)) Donor suitability procedures not followed (21 CFR 640.3(a)(1)) Qualifications of responsible personnel (21 CFR 606.20(b)) and 5 more |
Facility details
- Company
- Grifols Bio Supplies Inc
- Location
- Miami, FL (US)
- Source
- inspections