FDA Inspection 1103066 — Shalem Products Inc

Shalem Products Inc — FEI 1000139793

The FDA completed an inspection of Shalem Products Inc on September 24, 2019 in Angora, MN. 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
September 24, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Angora, MN (United States)

Citations

IDCFRDescription
360321 CFR 211.160(b)Scientifically sound laboratory controls