FDA Inspection 975165 — Niagara Pharmaceuticals Inc

Niagara Pharmaceuticals Inc — FEI 3003093882

The FDA completed an inspection of Niagara Pharmaceuticals Inc on May 16, 2016 in Dundas. 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
May 16, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dundas (Canada)

Citations

IDCFRDescription
179621 CFR 211.80(d)Identification of Each Lot in Each Shipment
188321 CFR 211.165(a)Testing and release for distribution