FDA Inspection 1280292 — SOFIE Co.

SOFIE Co. — FEI 3005705842

The FDA completed an inspection of SOFIE Co. on August 28, 2025 in Morgantown, WV. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Morgantown, WV (United States)

Citations

IDCFRDescription
2137321 CFR 212.30(b)Equipment procedures