FDA Inspection 1084188 — Navinta, LLC

Navinta, LLC — FEI 3004375014

The FDA completed an inspection of Navinta, LLC on March 28, 2019 in Ewing, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Ewing, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
683521 CFR 314.80(d)Failure to submit scientific article