FDA Inspection 1057855 — The Center for Fertility & Gynecology

The Center for Fertility & Gynecology — FEI 3005062270

The FDA completed an inspection of The Center for Fertility & Gynecology on June 29, 2018 in Tarzana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 29, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Tarzana, CA (United States)

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence