657967

Hawaiian Organic Noni LLC — FEI 3006312637

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 16, 2010
Fiscal Year
2010
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Anahola, HI (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
181021 CFR 211.160(a)Lab controls established, including changes
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
194321 CFR 211.180(e)(1)Review of representative number of batches
241921 CFR 211.198(a)Complaint Handling Procedure
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
356121 CFR 211.56(b)Written sanitation procedures lacking
433621 CFR 211.150Written distribution procedure
434021 CFR 211.142Written warehousing procedures established/followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews
900121 CFR 211.22(a)Lack of quality control unit