FDA Inspection
Presbyterian/St. Luke's Medical Center Donor ServicesPresbyterian/St. Luke's Medical Center Donor Services – FDA Inspection, Apr 22, 2019
Record Details
This FDA Inspection record concerns Presbyterian/St. Luke's Medical Center Donor Services, with an inspection on April 22, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 22, 2019
- Product Type
- Biologics
- Person
- Ismael Olvera-Iv (Issuing Officer)
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ID · 2b048a80-7cf3-4ba6-a75a-abdba36f7aeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087028
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
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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 |
| 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 |
| June 28, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Presbyterian/St. Luke's Medical Center Donor Services
- FDA Inspection 1233673 - 2024-03-07
- FDA Inspection 998973 - 2017-01-26
- FDA Inspection 868654 - 2014-03-05
- FDA Inspection 808541 - 2012-11-30
- FDA Inspection 786441 - 2012-06-28
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