FDA Inspection 1114751 — Frontier Therapeutics inc.

Frontier Therapeutics inc. — FEI 3015423385

The FDA completed an inspection of Frontier Therapeutics inc. on January 8, 2020 in Buffalo, NY. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 8, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Buffalo, NY (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures