FDA Inspection
St. Vincent Hospital and Health Care Inc.St. Vincent Hospital and Health Care Inc. – FDA Inspection, Jun 20, 2012
Record Details
This FDA Inspection record concerns St. Vincent Hospital and Health Care Inc., with an inspection on June 20, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 20, 2012
- Product Type
- Biologics
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ID · f11d3604-7bfe-4af1-90a6-1a5140f61573
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787512
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 640.2(c)(3)Blood not stored between 1-6 deg / shipped 1-10 deg
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of St. Vincent Hospital and Health Care Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 18, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 1, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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