FDA Inspection
East Texas Medical Center IrbEast Texas Medical Center Irb – FDA Inspection, Apr 17, 2009
Record Details
This FDA Inspection record concerns East Texas Medical Center Irb, with an inspection on April 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 17, 2009
- Product Type
- Drugs
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ID · 7d315e83-f3d2-4f0f-a5c5-ae533f7a599e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578721
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of East Texas Medical Center Irb
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 1, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for East Texas Medical Center Irb
- FDA Inspection 1157243 - 2021-10-08
- FDA Inspection 929834 - 2015-05-01
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