730609

Wisconsin Pharmacal Company — FEI 2124143

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2011
Fiscal Year
2011
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Jackson, WI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
1596321 CFR 111.113(b)(2)Quality control - reject; specification not met
189021 CFR 211.165(e)Test methods
192021 CFR 211.166(a)(3)Valid stability test methods
192621 CFR 211.166(b)Adequate number of batches on stability
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440221 CFR 211.192Written record of investigation incomplete
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
53721 CFR 820.70(a)Production processes