FDA Inspection
John M PagelJohn M Pagel – FDA Inspection, Feb 4, 2014
Record Details
This FDA Inspection record concerns John M Pagel, with an inspection on February 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- John M Pagel
- Inspection Date
- February 4, 2014
- Product Type
- Drugs
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ID · 26dba3d8-e714-462e-a5f2-a0e6009e5570
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871603
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of John M Pagel
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 9, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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