FDA Inspection 699952 — Diamond Wipes International, Inc.

Diamond Wipes International, Inc. — FEI 3003887639

The FDA completed an inspection of Diamond Wipes International, Inc. on November 5, 2010 in Chino, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 5, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chino, CA (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
202621 CFR 211.192Quality control unit review of records
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly