FDA Inspection
South Bend Medical Foundation, Inc.South Bend Medical Foundation, Inc. – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns South Bend Medical Foundation, Inc., with an inspection on September 11, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 11, 2009
- Product Type
- Biologics
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ID · 29008fe5-d8cf-4d3a-8d2b-d4da6b4af696
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613005
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of South Bend Medical Foundation, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | VAI | Detroit District Office | Blood and Blood Products |
| September 1, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 9, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 19, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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