FDA Inspection 877310 — Cardinal Health 414, LLC

Cardinal Health 414, LLC — FEI 3003411150

The FDA completed an inspection of Cardinal Health 414, LLC on May 1, 2014 in Colton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 1, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Colton, CA (United States)

Citations

IDCFRDescription
1776321 CFR 212.20(d)Determination need for investigation
1786421 CFR 212.60(g)(4)Statement of results and comparisons
1793421 CFR 212.60(g)(3)Laboratory Records Lack Required Data