FDA Inspection
Saint Lukes Memorial Hospital, Inc.Saint Lukes Memorial Hospital, Inc. – FDA Inspection, May 11, 2010
Record Details
This FDA Inspection record concerns Saint Lukes Memorial Hospital, Inc., with an inspection on May 11, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 11, 2010
- Product Type
- Biologics
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ID · ac6bba6e-65fc-4fd6-9807-98dc2d927010
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659338
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Saint Lukes Memorial Hospital, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 2, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 14, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Saint Lukes Memorial Hospital, Inc.
- FDA Inspection 1020841 - 2017-07-24
- FDA Inspection 933503 - 2015-07-02
- FDA Inspection 866263 - 2014-02-14
- FDA Inspection 788465 - 2012-06-28
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