FDA Inspection
Grifols Bio Supplies IncGrifols Bio Supplies Inc – FDA Inspection, Oct 20, 2010
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc, with an inspection on October 20, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Grifols Bio Supplies Inc
- Inspection Date
- October 20, 2010
- Product Type
- Biologics
View Company Profile
ID · 5cf731cd-40b0-4fa7-9863-484eb665faf6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680693
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 640.3(a)Donor suitability determined by unqualified person
- 21 CFR 640.52Collection
- 21 CFR 606.20(c)Exclusion of certain persons
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Grifols Bio Supplies Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 19, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 14, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 14, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc
- FDA Inspection 1314386 - 2026-04-23
- FDA Inspection 1206254 - 2023-05-19
- FDA Inspection 1083344 - 2019-03-14
- FDA Inspection 999080 - 2016-10-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.