FDA Inspection
Presbyterian/St. Luke's Medical Center Donor ServicesPresbyterian/St. Luke's Medical Center Donor Services – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Presbyterian/St. Luke's Medical Center Donor Services, with an inspection on January 26, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 26, 2017
- Product Type
- Biologics
View Company Profile
ID · 31c4496a-f9ed-4f8f-85f9-f072c49d2442
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998973
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 640.21(g)Informed consent
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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 |
| 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 1087028 - 2019-04-22
- FDA Inspection 868654 - 2014-03-05
- 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.