FDA Inspection 1102521 — Octapharma Plasma, Inc.

Octapharma Plasma, Inc. — FEI 3012375604

The FDA completed an inspection of Octapharma Plasma, Inc. on September 23, 2019 in Forestville, MD. 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
September 23, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Forestville, MD (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records