FDA Inspection
Paul D. Swenson, Ph.DPaul D. Swenson, Ph.D – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns Paul D. Swenson, Ph.D, with an inspection on February 14, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Paul D. Swenson, Ph.D
- Inspection Date
- February 14, 2011
- Product Type
- Biologics
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ID · 2ad69a42-fd0a-4e7c-9e6d-2a6259c474d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710760
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
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