FDA Inspection
Steward St. Elizabeth's Medical CenterSteward St. Elizabeth's Medical Center – FDA Inspection, Jan 31, 2017
Record Details
This FDA Inspection record concerns Steward St. Elizabeth's Medical Center, with an inspection on January 31, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b5224d80-00b7-405b-a95f-3f240ee58fbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000063
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Steward St. Elizabeth's Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 27, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 23, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Steward St. Elizabeth's Medical Center
- FDA Inspection 1109119 - 2019-10-03
- FDA Inspection 905496 - 2014-11-20
- FDA Inspection 824526 - 2013-03-27
- FDA Inspection 721585 - 2011-04-22
- FDA Inspection 598777 - 2009-07-23
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