FDA Inspection
MaineHealth IRB #1MaineHealth IRB #1 – FDA Inspection, Feb 12, 2010
Record Details
This FDA Inspection record concerns MaineHealth IRB #1, with an inspection on February 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- MaineHealth IRB #1
- Inspection Date
- February 12, 2010
- Product Type
- Drugs
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ID · 0c017c6f-fb47-4ebc-85d6-1770c8ad741a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648126
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.103(a)IRB review requirement
- 21 CFR 50.52Factors required for approval
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of MaineHealth IRB #1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2022 | NAI | Bioresearch Monitoring | |
| March 16, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for MaineHealth IRB #1
- FDA Inspection 1167287 - 2022-03-24
- FDA Inspection 962618 - 2016-03-16
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