FDA Inspection 1174847 — Main Line Fertility Center

Main Line Fertility Center — FEI 3004169562

The FDA completed an inspection of Main Line Fertility Center on June 30, 2022 in Bryn Mawr, PA. 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 30, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Bryn Mawr, PA (United States)

Citations

IDCFRDescription
1225221 CFR 1271.60(a)Completion of eligibility determination
1249321 CFR 1271.90(c)Eligibility not required--warning labels