FDA Inspection 991565 — ASIO Holdings, LLC

ASIO Holdings, LLC — FEI 3003099171

The FDA completed an inspection of ASIO Holdings, LLC on November 2, 2016 in Lake Forest, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 2, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Forest, IL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
194221 CFR 211.180(e)Records reviewed annually