FDA Inspection 797008 — Blistex Inc

Blistex Inc — FEI 1413077

The FDA completed an inspection of Blistex Inc on Aug 31, 2012 in Oak Brook, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 31, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oak Brook, IL (United States)

Citations

IDCFRDescription
189021 CFR 211.165(e)Test methods
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls

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