FDA Inspection 619115 — Vapco Incorporated

Vapco Incorporated — FEI 1219408

The FDA completed an inspection of Vapco Incorporated on September 25, 2009 in Lawrence, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 25, 2009
Fiscal Year
2009
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Lawrence, MA (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
432421 CFR 211.110(b)In-process materials specifications testing
436621 CFR 211.188(a)Accurate reproduction included
437721 CFR 211.188(b)(3)Identification of each component or in-process material
900121 CFR 211.22(a)Lack of quality control unit