FDA Inspection 1162807 — PI Pharma Inc

PI Pharma Inc — FEI 3006481857

The FDA completed an inspection of PI Pharma Inc on February 15, 2022 in Campton, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 15, 2022
Fiscal Year
2022
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Campton, KY (United States)

Citations

IDCFRDescription
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583121 CFR 111.70(b)(3)Specifications - contamination limits
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1588221 CFR 111.75(h)Tests, examinations - scientifically valid