FDA Inspection
Grifols Bio Supplies IncGrifols Bio Supplies Inc – FDA Inspection, Dec 22, 2010
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc, with an inspection on December 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Grifols Bio Supplies Inc
- Inspection Date
- December 22, 2010
- Product Type
- Biologics
View Company Profile
ID · fc1d6158-2b8e-41da-b3b5-8e14a0604873
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699828
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 660.32Same as for whole blood
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 630.40(a)Notification
- 21 CFR 606.100(c)Thorough investigations
- 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
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 20, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 12, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc
- FDA Inspection 1249252 - 2024-08-13
- FDA Inspection 1113066 - 2019-11-08
- FDA Inspection 995541 - 2016-12-13
- FDA Inspection 920015 - 2015-02-20
- FDA Inspection 825221 - 2013-03-12
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