FDA Inspection
Banco de Sangre Servicios Mutuos, Inc. [Hnos. Mdez]Banco de Sangre Servicios Mutuos, Inc. [Hnos. Mdez] – FDA Inspection, Jun 12, 2009
Record Details
This FDA Inspection record concerns Banco de Sangre Servicios Mutuos, Inc. [Hnos. Mdez], with an inspection on June 12, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 12, 2009
- Product Type
- Biologics
View Company Profile
ID · b73ded62-c581-4246-9635-b69e2890025d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 598906
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 640.4(h)Storage temperatures after collection
- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 640.3(c)(1)History of viral hepatitis
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Banco de Sangre Servicios Mutuos, Inc. [Hnos. Mdez]
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 16, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 30, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 6, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Banco de Sangre Servicios Mutuos, Inc. [Hnos. Mdez]
- FDA Inspection 967753 - 2016-02-04
- FDA Inspection 887557 - 2014-07-16
- FDA Inspection 805449 - 2012-10-30
- FDA Inspection 730772 - 2011-05-06
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