790155

Dextrum Laboratories — FEI 3003092372

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 10, 2012
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Miami, FL (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
135821 CFR 211.100(b)SOPs not followed / documented
181021 CFR 211.160(a)Lab controls established, including changes
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include
432021 CFR 211.84(d)(6)Microbiological Contamination Exam
437421 CFR 211.188(b)(6)Inspection of packaging and labeling area