FDA Inspection
New York City Department of Health & Mental Hygiene IRBNew York City Department of Health & Mental Hygiene IRB – FDA Inspection, Apr 1, 2013
Record Details
This FDA Inspection record concerns New York City Department of Health & Mental Hygiene IRB, with an inspection on April 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 1, 2013
- Product Type
- Drugs
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ID · 6ffae4b5-b72a-42a6-a627-ae58f5223a90
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 824916
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.104(c)Emergency use and IRB approval
- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.106(e)Changes in contact or chairperson information
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.107(a)At least five members with varying backgrounds
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Other FDA inspections of New York City Department of Health & Mental Hygiene IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for New York City Department of Health & Mental Hygiene IRB
- FDA Inspection 900892 - 2014-10-23
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