FDA Inspection
Hospital Comunitario Buen Samaritano, Inc.Hospital Comunitario Buen Samaritano, Inc. – FDA Inspection, Mar 27, 2013
Record Details
This FDA Inspection record concerns Hospital Comunitario Buen Samaritano, Inc., with an inspection on March 27, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 27, 2013
- Product Type
- Biologics
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ID · 7561ddea-ec3f-4993-adc1-b018332ad3fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824491
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Hospital Comunitario Buen Samaritano, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2016 | Not classified | San Juan District Office | |
| January 28, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 9, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 3, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Hospital Comunitario Buen Samaritano, Inc.
- FDA Inspection 994792 - 2016-11-17
- FDA Inspection 912078 - 2015-01-28
- FDA Inspection 755730 - 2011-11-09
- FDA Inspection 659597 - 2010-05-03
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