FDA Inspection 838863 — WATKINS PRODUCTS INC

WATKINS PRODUCTS INC — FEI 2111972

The FDA completed an inspection of WATKINS PRODUCTS INC on Jun 28, 2013 in Winona, MN. 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 28, 2013
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Winona, MN (United States)

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
115921 CFR 211.28(a)Clothing appropriate for duties performed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
194221 CFR 211.180(e)Records reviewed annually
203521 CFR 211.194(e)Stability testing records not included
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages