FDA Inspection 824267 — Cardinal Biologicals, Inc.

Cardinal Biologicals, Inc. — FEI 3003571688

The FDA completed an inspection of Cardinal Biologicals, Inc. on Mar 27, 2013 in Cape Girardeau, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Mar 27, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Cape Girardeau, MO (United States)

Citations

IDCFRDescription
11621 CFR 606.121(e)Container label requirements - particular products
15521 CFR 606.160(b)Required records
9721 CFR 606.100(b)(18)Procedure for preparing recovered (salvaged) plasma