FDA Inspection
South Bend Medical Foundation, Inc.South Bend Medical Foundation, Inc. – FDA Inspection, Jul 6, 2012
Record Details
This FDA Inspection record concerns South Bend Medical Foundation, Inc., with an inspection on July 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 6, 2012
- Product Type
- Biologics
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ID · f0fdd761-8fbe-4786-be89-658879c61f75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789743
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 640.4(f)Arm preparation
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Other FDA inspections of South Bend Medical Foundation, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for South Bend Medical Foundation, Inc.
- FDA Inspection 884958 - 2014-06-24
- FDA Inspection 677243 - 2010-08-20
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