First Choice Importing Inc. – FDA Warning Letter, Aug 18, 2022

On January 12, 2023, the FDA issued a Warning Letter to First Choice Importing Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 27 to August 18, 2022, and a previous inspection from August 6 to 14, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The FDA found significant violations, specifically that First Choice Importing Inc. failed to develop, maintain, and follow an FSVP for any imported foods, including funnel cake, black tea, and instant noodles. This violates 21 CFR 1.502(a). The company did not respond to the original or amended Form FDA 483a provided by the investigator.

While the company may qualify as a "very small importer" under 21 CFR 1.500, requiring compliance with modified requirements in 21 CFR 1.512, they must still document this status (21 CFR 1.512(b)(1)(i)) and comply with 21 CFR 1.502, 1.503, and 1.509. Additionally, they must obtain written assurance from foreign suppliers every two years that food production meets U.S. food safety standards (