FDA Inspection 1018429 — One Way Drug, LLC

One Way Drug, LLC — FEI 3010839113

The FDA completed an inspection of One Way Drug, LLC on Jul 19, 2017 in Las Vegas, NV. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI)
End Date
Jul 19, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Las Vegas, NV (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
188321 CFR 211.165(a)Testing and release for distribution
189121 CFR 211.165(f)Failing drug products not rejected

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