FDA Inspection 721846 — Concept Laboratories, Inc.

Concept Laboratories, Inc. — FEI 1000639361

The FDA completed an inspection of Concept Laboratories, Inc. on April 8, 2011 in Pleasant Prairie, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2011
Fiscal Year
2011
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Pleasant Prairie, WI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
241921 CFR 211.198(a)Complaint Handling Procedure
440221 CFR 211.192Written record of investigation incomplete