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FDA Inspection
•Kirk Sperber, M.D.•June 10, 2011

Kirk Sperber, M.D. – FDA Inspection, Jun 10, 2011

Record Details

This FDA Inspection record concerns Kirk Sperber, M.D., with an inspection on June 10, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Kirk Sperber, M.D.
Inspection Date
June 10, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · f15c100c-42dc-473b-af97-8085f7ad5a99

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
724512
FDA center
Biologics
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.60Informed consent
  3. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  4. 21 CFR 312.62(c)Record retention

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