FDA Inspection 945585 — Eon Labs Inc

Eon Labs Inc — FEI 3000210731

The FDA completed an inspection of Eon Labs Inc on August 13, 2015 in Wilson, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 13, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilson, NC (United States)

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
356521 CFR 211.58Buildings not maintained in good state of repair