FDA Inspection
Saint Lukes Memorial Hospital, Inc.Saint Lukes Memorial Hospital, Inc. – FDA Inspection, Jun 28, 2012
Record Details
This FDA Inspection record concerns Saint Lukes Memorial Hospital, Inc., with an inspection on June 28, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 28, 2012
- Product Type
- Biologics
View Company Profile
ID · 753293d1-a6b8-435c-be76-e9f8ee5d4343
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788465
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 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 |
| May 11, 2010 | 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 659338 - 2010-05-11
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