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FDA Inspection
•UCSF Center for Reproductive Health-Marin•June 26, 2009

UCSF Center for Reproductive Health-Marin – FDA Inspection, Jun 26, 2009

Record Details

This FDA Inspection record concerns UCSF Center for Reproductive Health-Marin, with an inspection on June 26, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
UCSF Center for Reproductive Health-Marin
Inspection Date
June 26, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 27500b3d-7f1a-49e1-aef2-2e4b70830141

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
600966
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.47(c)Availability of procedures
  2. 21 CFR 1271.50(a)Determination based on screening and testing
  3. 21 CFR 1271.47(a)Procedures for all other requirements
  4. 21 CFR 1271.80(c)Test lab not certified or equivalent

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