FDA Inspection 1242060 — Charles Masson USA, Inc.

Charles Masson USA, Inc. — FEI 3016504135

The FDA completed an inspection of Charles Masson USA, Inc. on June 18, 2024 in Bethel, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2024
Fiscal Year
2024
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Bethel, CT (United States)

Additional Details

FSVP

Citations

IDCFRDescription
1826221 CFR 1.504(a)Hazard analysis written
1826321 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
1828121 CFR 1.505(a)(2)Evaluation - performance, risk
1828821 CFR 1.505(d)Evaluation, reevaluation - another entity
1828921 CFR 1.505(d)Evaluation, reevaluation - qualified individual
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
1829621 CFR 1.506(d)(1)(i)Verification activity frequency
1830321 CFR 1.506(e)(1)Verification activity before import, periodically
1830621 CFR 1.506(e)(1)(i)(D)Audit - document
1831321 CFR 1.506(e)(3)Verification activity review, assess
1833421 CFR 1.510(b)(1)Record - translate to English