FDA Inspection 1294034 — Indigo Foods USA, LLC

Indigo Foods USA, LLC — FEI 3014127147

The FDA completed an inspection of Indigo Foods USA, LLC on December 5, 2025 in Harrisburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 5, 2025
Fiscal Year
2026
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Harrisburg, PA (United States)

Additional Details

FSVP

Citations

IDCFRDescription
1826221 CFR 1.504(a)Hazard analysis written
1828321 CFR 1.505(b)Supplier approval - document
1829021 CFR 1.506(a)(1)Approved supplier procedures - importer established
1829321 CFR 1.506(b)Supplier verification - establish written procedures
1829521 CFR 1.506(d)(1)(i)Verification activity assurance
2241721 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
2243121 CFR 1.505(b)Supplier approval - document
2243921 CFR 1.506(a)(1)Approved supplier procedures - importer established
2244221 CFR 1.506(b)Supplier verification - establish written procedures
2244421 CFR 1.506(d)(1)(i)Verification activity assurance
2245221 CFR 1.506(e)(1)Verification activity before import, periodically