FDA Inspection 939452 — Biomat USA, Inc

Biomat USA, Inc — FEI 2377743

The FDA completed an inspection of Biomat USA, Inc on July 28, 2015 in El Paso, 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
July 28, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
El Paso, TX (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation