FDA Inspection
Nebraska Methodist HospitalNebraska Methodist Hospital – FDA Inspection, Jun 11, 2009
Record Details
This FDA Inspection record concerns Nebraska Methodist Hospital, with an inspection on June 11, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Nebraska Methodist Hospital
- Inspection Date
- June 11, 2009
- Product Type
- Biologics
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ID · 42946b17-2819-4b74-a690-d9cb2abfa494
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596989
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Nebraska Methodist Hospital
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2025 | Not classified | Kansas City District Office | |
| May 9, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Nebraska Methodist Hospital
- FDA Inspection 1263572 - 2025-02-26
- FDA Inspection 1169668 - 2022-05-09
- FDA Inspection 1036906 - 2017-11-28
- FDA Inspection 954715 - 2015-12-18
- FDA Inspection 952572 - 2015-12-17
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