694940

Columbia Cosmetics Manufacturing, Inc. — FEI 2919184

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Leandro, CA (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
179621 CFR 211.80(d)Identification of Each Lot in Each Shipment
200921 CFR 211.188Prepared for each batch, include complete information
356921 CFR 211.89Quarantine of Rejected Components et. al.
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
439121 CFR 211.180(e)(2)Items to cover on annual reviews