FDA Inspection 1110468 — ELM, Inc.

ELM, Inc. — FEI 3011118872

The FDA completed an inspection of ELM, Inc. on November 7, 2019 in Carolina, PR. 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
November 7, 2019
Fiscal Year
2020
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Carolina, PR (United States)

Citations

IDCFRDescription
1813821 CFR 117.10Personnel
1814021 CFR 117.20(b)Plant construction and design
1814121 CFR 117.35(a)Sanitary operations - Plant maintenance
1814221 CFR 117.35(a)Sanitary operations - Plant sanitation