FDA Inspection
Jau-Shin Lou, MD, Ph.D.Jau-Shin Lou, MD, Ph.D. – FDA Inspection, Feb 29, 2012
Record Details
This FDA Inspection record concerns Jau-Shin Lou, MD, Ph.D., with an inspection on February 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Jau-Shin Lou, MD, Ph.D.
- Inspection Date
- February 29, 2012
- Product Type
- Biologics
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ID · c5f3b970-dc91-44e3-9048-3252fa61e3cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771099
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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