FDA Inspection 1120774 — Kendrick Laboratories

Kendrick Laboratories — FEI 3001238747

The FDA completed an inspection of Kendrick Laboratories on March 10, 2020 in Madison, WI. 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
March 10, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Madison, WI (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls