FDA Inspection
Allendale IRBAllendale IRB – FDA Inspection, Sep 24, 2015
Record Details
This FDA Inspection record concerns Allendale IRB, with an inspection on September 24, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Allendale IRB
- Inspection Date
- September 24, 2015
- Product Type
- Biologics
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ID · a01ef777-c4fd-4638-8bcd-e15e65a13a9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946552
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Allendale IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2020 | NAI | Bioresearch Monitoring | |
| February 23, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Allendale IRB
- FDA Inspection 1122441 - 2020-03-19
- FDA Inspection 713978 - 2011-02-23
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