FDA Inspection
Phase One Solutions, Inc.Phase One Solutions, Inc. – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Phase One Solutions, Inc., with an inspection on December 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Phase One Solutions, Inc.
- Inspection Date
- December 1, 2011
- Product Type
- Drugs
View Company Profile
ID · 2bfc8433-6ac5-4418-a656-5dae56a487a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759849
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.66Changes in research
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Other FDA inspections of Phase One Solutions, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2016 | Not classified | Florida District Office |
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