Grifols Bio Supplies Inc — FDA Facility Profile

FEI 1049760

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

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 23, 2026No Action Indicated (NAI)No citations listed
May 19, 2023No Action Indicated (NAI)No citations listed
Mar 14, 2019Voluntary Action Indicated (VAI)When to report (21 CFR 600.14(c))
Oct 14, 2016Voluntary 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, 2010Official 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

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.