FDA Inspection 917359 — Curasan, Inc.

Curasan, Inc. — FEI 3007346541

The FDA completed an inspection of Curasan, Inc. on Mar 9, 2015 in Wake Forest, NC. 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). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 9, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Wake Forest, NC (United States)

Citations

IDCFRDescription
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained