FDA Inspection 766279 — Merial Limited

Merial Limited — FEI 3004468368

The FDA completed an inspection of Merial Limited on Jan 25, 2012 in N Brunswick, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 25, 2012
Fiscal Year
2012
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
N Brunswick, NJ (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
189021 CFR 211.165(e)Test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.