FDA Inspection
Nebraska Methodist HospitalNebraska Methodist Hospital – FDA Inspection, Dec 18, 2015
Record Details
This FDA Inspection record concerns Nebraska Methodist Hospital, with an inspection on December 18, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Nebraska Methodist Hospital
- Inspection Date
- December 18, 2015
- Product Type
- Drugs
View Company Profile
ID · 70cfe7ee-4b0e-4ec8-b4fd-27bee58818e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954715
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- State Referral Letter
FDA Citations
4- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
Full citation text and observation details available on the Dashboard.
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 17, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 952572 - 2015-12-17
- FDA Inspection 888147 - 2014-07-14
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.