FDA Inspection 1103215 — H. W. Naylor Company Inc.

H. W. Naylor Company Inc. — FEI 1311614

The FDA completed an inspection of H. W. Naylor Company Inc. on September 26, 2019 in Morris, NY. 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
September 26, 2019
Fiscal Year
2019
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Morris, NY (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance