FDA Inspection 1092540 — Sage Products, LLC

Sage Products, LLC — FEI 1419181

The FDA completed an inspection of Sage Products, LLC on June 7, 2019 in Cary, 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
June 7, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cary, IL (United States)

Citations

IDCFRDescription
360221 CFR 211.160(a)Deviations from laboratory control requirements
457621 CFR 211.192No written record of investigation