FDA Inspection 1209583 — Avanti Polar Lipids

Avanti Polar Lipids — FEI 1036868

The FDA completed an inspection of Avanti Polar Lipids on July 7, 2023 in Alabaster, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 7, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alabaster, AL (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records