First Choice Importing Inc. Warning Letter Details

Summary

First Choice Importing Inc. failed to comply with the Foreign Supplier Verification Program (FSVP) requirements for food and beverage products imported into the United States, including funnel cake and black tea. The company did not develop, maintain, or follow any FSVP plan as required by section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L, despite receiving FDA 483a observations during inspections conducted between June and August 2022. The company did not respond to the original or amended Form FDA 483a issued following the inspection, leaving the significant violations unaddressed.