660339

Biomat USA Inc — FEI 2077733

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 21, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Reseda, CA (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
924121 CFR 630.40(a)Supplemental results
924321 CFR 630.40(a)Notification