FDA Inspection 998568 — RiconPharma LLC

RiconPharma LLC — FEI 3007236518

The FDA completed an inspection of RiconPharma LLC on January 9, 2017 in Denville, 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
January 9, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Denville, NJ (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records