FDA Inspection 774401 — Biomat USA Inc (Birmingham Location #2)

Biomat USA Inc (Birmingham Location #2) — FEI 1072510

The FDA completed an inspection of Biomat USA Inc (Birmingham Location #2) on March 30, 2012 in Birmingham, AL. 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 30, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Birmingham, AL (United States)

Citations

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