FDA Inspection
Hospital Comunitario Buen Samaritano, Inc.Hospital Comunitario Buen Samaritano, Inc. – FDA Inspection, Nov 9, 2011
Record Details
This FDA Inspection record concerns Hospital Comunitario Buen Samaritano, Inc., with an inspection on November 9, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 9, 2011
- Product Type
- Biologics
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ID · 1c4a1081-c04e-4205-af0b-c972bf0d7385
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755730
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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 |
| March 27, 2013 | 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 824491 - 2013-03-27
- FDA Inspection 659597 - 2010-05-03
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