FDA Inspection
Presbyterian/St. Luke's Medical Center Donor ServicesPresbyterian/St. Luke's Medical Center Donor Services – FDA Inspection, Nov 24, 2009
Record Details
This FDA Inspection record concerns Presbyterian/St. Luke's Medical Center Donor Services, with an inspection on November 24, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 24, 2009
- Product Type
- Biologics
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ID · 12e18fdb-1c16-4947-bde5-a701144eac8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637133
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 640.120Alternative procedures
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)(1)Donor criteria
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Presbyterian/St. Luke's Medical Center Donor Services
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 26, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Presbyterian/St. Luke's Medical Center Donor Services
- FDA Inspection 1233673 - 2024-03-07
- FDA Inspection 1087028 - 2019-04-22
- FDA Inspection 998973 - 2017-01-26
- FDA Inspection 868654 - 2014-03-05
- FDA Inspection 808541 - 2012-11-30
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