FDA Inspection 1156306 — Ava Inc

Ava Inc — FEI 3008736380

The FDA completed an inspection of Ava Inc on September 29, 2021 in Willowbrook, 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
September 29, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Willowbrook, IL (United States)

Citations

IDCFRDescription
154021 CFR 211.125(a)Strict control not exercised over labeling issued
155021 CFR 211.125(f)Procedures Written and Followed