FDA Inspection 1233914 — Octapharma Plasma, Inc.

Octapharma Plasma, Inc. — FEI 3012288516

The FDA completed an inspection of Octapharma Plasma, Inc. on March 22, 2024 in Dallas, TX. 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
March 22, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Dallas, TX (United States)

Citations

IDCFRDescription
6121 CFR 606.60(a)Provide proper equipment to meet requirements