FDA Inspection 642601 — Biomat USA Inc

Biomat USA Inc — FEI 3000717632

The FDA completed an inspection of Biomat USA Inc on Feb 1, 2010 in Toledo, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 1, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Toledo, OH (United States)

Citations

IDCFRDescription
908921 CFR 600.14(c)When to report
922521 CFR 606.171Biological product deviation report
924321 CFR 630.40(a)Notification