FDA Inspection 1203902 — Advanced Reproductive Center of Hawaii

Advanced Reproductive Center of Hawaii — FEI 3005208550

The FDA completed an inspection of Advanced Reproductive Center of Hawaii on April 28, 2023 in Honolulu, HI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 28, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Honolulu, HI (United States)

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence