FDA Inspection
Faxton St. Lukes Healthcare IRBFaxton St. Lukes Healthcare IRB – FDA Inspection, Jun 27, 2014
Record Details
This FDA Inspection record concerns Faxton St. Lukes Healthcare IRB, with an inspection on June 27, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 27, 2014
- Product Type
- Drugs
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ID · d0b14547-5614-4961-9631-95f9d4a6bd02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886543
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.107(d)One non-affiliate member
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Other FDA inspections of Faxton St. Lukes Healthcare IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2022 | NAI | Bioresearch Monitoring |
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