FDA Inspection
South Bend Medical Foundation, Inc.South Bend Medical Foundation, Inc. – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns South Bend Medical Foundation, Inc., with an inspection on November 9, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b3245e16-03b6-4f1f-8fb2-aec399f82ee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071283
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of South Bend Medical Foundation, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 17, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 12, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for South Bend Medical Foundation, Inc.
- FDA Inspection 1232833 - 2024-02-01
- FDA Inspection 993233 - 2016-11-22
- FDA Inspection 918388 - 2015-03-17
- FDA Inspection 826927 - 2013-04-12
- FDA Inspection 741485 - 2011-08-25
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