FDA Inspection
Population Council (The)Population Council (The) – FDA Inspection, Mar 11, 2016
Record Details
This FDA Inspection record concerns Population Council (The), with an inspection on March 11, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Population Council (The)
- Inspection Date
- March 11, 2016
- Product Type
- Drugs
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ID · 44196a72-8bd7-4ff2-98cc-afe6ff0ff105
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963100
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Population Council (The)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 30, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Population Council (The)
- FDA Inspection 1046895 - 2018-03-14
- FDA Inspection 653236 - 2010-03-30
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