FDA Inspection 1002848 — Centaur Pharmaceuticals Private Ltd.

Centaur Pharmaceuticals Private Ltd. — FEI 3008861619

The FDA completed an inspection of Centaur Pharmaceuticals Private Ltd. on November 14, 2016 in Pune. 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
November 14, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pune (India)

Citations

IDCFRDescription
144821 CFR 211.111Establishment of time limitations
191221 CFR 211.166(a)Written program not followed