FDA Inspection 782477 — The Original Bradford Soap Works, Inc.

The Original Bradford Soap Works, Inc. — FEI 1211888

The FDA completed an inspection of The Original Bradford Soap Works, Inc. on May 23, 2012 in West Warwick, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 23, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Warwick, RI (United States)

Citations

IDCFRDescription
180321 CFR 211.84(b)Representative Samples Criteria
191221 CFR 211.166(a)Written program not followed
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
432321 CFR 211.115(a)Reprocessing procedures lack steps to be taken