FDA Inspection
Grifols Bio Supplies IncGrifols Bio Supplies Inc – FDA Inspection, Oct 19, 2009
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc, with an inspection on October 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Grifols Bio Supplies Inc
- Inspection Date
- October 19, 2009
- Product Type
- Biologics
View Company Profile
ID · 7cfc33f5-f2d4-40b2-a965-51978fcd77f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 621295
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 630.40(c)Notification w/in 8 weeks
- 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
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 9, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 20, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc
- FDA Inspection 1179598 - 2022-08-29
- FDA Inspection 1059172 - 2018-06-06
- FDA Inspection 986156 - 2016-09-09
- FDA Inspection 887748 - 2014-07-17
- FDA Inspection 778001 - 2012-04-20
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.