FDA Inspection
Grifols Bio Supplies IncGrifols Bio Supplies Inc – FDA Inspection, Dec 10, 2009
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc, with an inspection on December 10, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Grifols Bio Supplies Inc
- Inspection Date
- December 10, 2009
- Product Type
- Biologics
View Company Profile
ID · 35bf3e6a-1e38-4c1a-aaf9-ba54d9a69143
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636435
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 640.4(f)Closed system
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(7)Methods for performance of all tests
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
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Other FDA inspections of Grifols Bio Supplies Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 4, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 24, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc
- FDA Inspection 1316538 - 2026-04-29
- FDA Inspection 1158853 - 2021-12-10
- FDA Inspection 1035757 - 2017-11-01
- FDA Inspection 967287 - 2016-03-04
- FDA Inspection 877379 - 2014-03-24
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