Aroma Imports, Inc. Warning Letter Details

Summary

Aroma Imports, Inc., a food and beverage importer, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation under 21 CFR Part 1, Subpart L during FDA inspections conducted in December 2020 and August 2021. The company did not obtain written assurances from foreign suppliers demonstrating compliance with U.S. food safety standards, a requirement that must be completed before importing food and renewed at least every two years. The FDA also noted that the company failed to respond to a Form FDA 483a issued on August 26, 2021, documenting the FSVP observations identified during the inspection.