FDA Inspection 1025933 — Actavis Pharma Development Centre Private Ltd

Actavis Pharma Development Centre Private Ltd — FEI 3007127164

The FDA completed an inspection of Actavis Pharma Development Centre Private Ltd on September 21, 2017 in Chennai. 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
September 21, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chennai (India)

Citations

IDCFRDescription
192021 CFR 211.166(a)(3)Valid stability test methods
440321 CFR 211.194(b)Test method modification records do not include