FDA Inspection 776516 — Arcade Marketing Inc.

Arcade Marketing Inc. — FEI 3002986405

The FDA completed an inspection of Arcade Marketing Inc. on April 10, 2012 in Chattanooga, TN. 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
April 10, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chattanooga, TN (United States)

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution
192021 CFR 211.166(a)(3)Valid stability test methods
434221 CFR 211.142(b)Storage under appropriate conditions