FDA Inspection
Roper St Francis Mount Pleasant HospitalRoper St Francis Mount Pleasant Hospital – FDA Inspection, Nov 16, 2017
Record Details
This FDA Inspection record concerns Roper St Francis Mount Pleasant Hospital, with an inspection on November 16, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 16, 2017
- Product Type
- Biologics
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ID · c24ea8c3-eefa-42dd-b8d0-75b47e4f34b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031711
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
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Other FDA inspections of Roper St Francis Mount Pleasant Hospital
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 25, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 13, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Roper St Francis Mount Pleasant Hospital
- FDA Inspection 956707 - 2016-02-02
- FDA Inspection 824021 - 2013-03-25
- FDA Inspection 747710 - 2011-09-13
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