FDA Inspection
Sheila M. Specker, MD, Clinical InvestigatorSheila M. Specker, MD, Clinical Investigator – FDA Inspection, Feb 4, 2015
Record Details
This FDA Inspection record concerns Sheila M. Specker, MD, Clinical Investigator, with an inspection on February 4, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 4, 2015
- Product Type
- Drugs
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ID · 8ce38142-3d8b-458a-97e4-d9eba9bf7cc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909880
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.56(c)Annual report
- 21 CFR 312.66Changes in research
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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