FDA Inspection
The Nebraska Medical CenterThe Nebraska Medical Center – FDA Inspection, Dec 2, 2010
Record Details
This FDA Inspection record concerns The Nebraska Medical Center, with an inspection on December 2, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- The Nebraska Medical Center
- Inspection Date
- December 2, 2010
- Product Type
- Biologics
View Company Profile
ID · 934f96d1-573e-4999-a556-9dc75210e6bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 700971
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 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 The Nebraska Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 24, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 19, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for The Nebraska Medical Center
- FDA Inspection 1202909 - 2023-04-11
- FDA Inspection 1077742 - 2018-12-13
- FDA Inspection 1025781 - 2017-08-24
- FDA Inspection 935814 - 2015-06-23
- FDA Inspection 803217 - 2012-10-19
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.