FDA Inspection 859546 — Biomat USA, Inc.

Biomat USA, Inc. — FEI 3007044092

The FDA completed an inspection of Biomat USA, Inc. on December 17, 2013 in Lakewood, CO. 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
December 17, 2013
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Lakewood, CO (United States)

Citations

IDCFRDescription
4121 CFR 606.40(a)(1)Provide space for examination