FDA Inspection 1038753 — Cardinal Health 414, Inc.

Cardinal Health 414, Inc. — FEI 3003706047

The FDA completed an inspection of Cardinal Health 414, Inc. on Jan 25, 2018 in Seattle, WA. 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). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 25, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Seattle, WA (United States)

Citations

IDCFRDescription
1772321 CFR 212.10Personnel not qualified
1776321 CFR 212.20(d)Determination need for investigation
1781221 CFR 212.50Adequate controls (general)
1785121 CFR 212.60(c)Analytical methods

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.