FDA Inspection 663574 — Grifols Bio Supplies Inc.

Grifols Bio Supplies Inc. — FEI 1177773

The FDA completed an inspection of Grifols Bio Supplies Inc. on May 18, 2010 in Baltimore, 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
May 18, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Baltimore, MD (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs