FDA Inspection
Saint Elizabeth Med Ctr IRBSaint Elizabeth Med Ctr IRB – FDA Inspection, May 3, 2010
Record Details
This FDA Inspection record concerns Saint Elizabeth Med Ctr IRB, with an inspection on May 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Saint Elizabeth Med Ctr IRB
- Inspection Date
- May 3, 2010
- Product Type
- Drugs
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ID · 56b91f81-baf7-4348-a534-e2ac28ccf6a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655819
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.106(a)IRB for CI"s in support of research/marketing permits
- 21 CFR 56.113Reporting
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Other FDA inspections of Saint Elizabeth Med Ctr IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Saint Elizabeth Med Ctr IRB
- FDA Inspection 961091 - 2016-03-09
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