FDA Inspection 1274447 — AMI Newco, LLC

AMI Newco, LLC — FEI 3004305343

The FDA completed an inspection of AMI Newco, LLC on Jun 20, 2025 in Carson City, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 20, 2025
Fiscal Year
2025
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Carson City, NV (United States)

Citations

IDCFRDescription
1583821 CFR 111.70(d)Specifications - labels, packaging
1586921 CFR 111.75(c)Specifications met - verify; finished batch
2285921 CFR 111.103Written procedures - establish; quality control operations
2288821 CFR 111.210Master manufacturing record - record requirements

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.