680644

New Spirit Naturals Inc. — FEI 3003815957

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 7, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Dimas, CA (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented
177421 CFR 211.142(a)Quarantine - actual practice
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
194221 CFR 211.180(e)Records reviewed annually
430721 CFR 211.80(d)Status of Each Lot Identified
434021 CFR 211.142Written warehousing procedures established/followed
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies