FDA Inspection
Grifols Bio Supplies Inc.Grifols Bio Supplies Inc. – FDA Inspection, Apr 2, 2012
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc., with an inspection on April 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Grifols Bio Supplies Inc.
- Inspection Date
- April 2, 2012
- Product Type
- Biologics
View Company Profile
ID · 291ce2d8-70ce-43b3-8b4b-5a3d7b54e038
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774262
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 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
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Other FDA inspections of Grifols Bio Supplies Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 18, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 2, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc.
- FDA Inspection 1173907 - 2022-06-28
- FDA Inspection 1080666 - 2019-01-18
- FDA Inspection 1022920 - 2017-07-20
- FDA Inspection 932350 - 2015-07-02
- FDA Inspection 854893 - 2013-11-13
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