FDA Inspection
Presbyterian/St. Luke's Medical Center Donor ServicesPresbyterian/St. Luke's Medical Center Donor Services – FDA Inspection, Mar 5, 2014
Record Details
This FDA Inspection record concerns Presbyterian/St. Luke's Medical Center Donor Services, with an inspection on March 5, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 5, 2014
- Product Type
- Biologics
View Company Profile
ID · 155061bc-388a-4d89-848e-4f1c36fecd6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868654
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
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 |
| 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 1087028 - 2019-04-22
- FDA Inspection 998973 - 2017-01-26
- FDA Inspection 808541 - 2012-11-30
- FDA Inspection 786441 - 2012-06-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.