Grifols Bio Supplies Inc — FDA Facility Profile
Grifols Bio Supplies Inc is an FDA-inspected facility (FEI 3000719222) located in Philadelphia, PA, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 13, 2024: No Action Indicated (NAI)
- Inspections on record
- 8 (5 VAI, 3 NAI)
- Last OAI inspection
- None on record
- 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 |
|---|---|---|
| Aug 13, 2024 | No Action Indicated (NAI) | No citations listed |
| Nov 8, 2019 | No Action Indicated (NAI) | No citations listed |
| Dec 13, 2016 | Voluntary Action Indicated (VAI) | Cumulative deferral record HTLV, Chagas (21 CFR 606.160(e)(2)) Test for HTLV, syphilis, West Nile, Chagas (21 CFR 610.40(a)(2)) Additional Medical Assessment Factors (21 CFR 630.10(e)(2)) Proof Of Identity (21 CFR 630.10(g)(1)) and 1 more |
| Feb 20, 2015 | Voluntary Action Indicated (VAI) | Notification (21 CFR 630.40(a)) |
| Mar 12, 2013 | Voluntary Action Indicated (VAI) | Same as for whole blood (21 CFR 660.32) Thorough investigations (21 CFR 606.100(c)) |
| Apr 11, 2012 | No Action Indicated (NAI) | No citations listed |
| Dec 22, 2010 | Voluntary Action Indicated (VAI) | Donor suitability procedures not followed (21 CFR 640.3(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Notification (21 CFR 630.40(a)) Same as for whole blood (21 CFR 660.32) and 1 more |
| Mar 3, 2009 | Voluntary Action Indicated (VAI) | Same as for whole blood donor (21 CFR 660.31) Same as for whole blood (21 CFR 660.32) |
Facility details
- Company
- Grifols Bio Supplies Inc
- Location
- Philadelphia, PA (US)
- Source
- inspections