FDA WARNING_LETTER - La Sucursal Produce Inc. - October 25, 2023

On October 25, 2023, the FDA conducted an FSVP inspection at La Sucursal Produce Inc., following previous inspections on May 3, 2019, and August 16, 2022. The inspection revealed significant violations of the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act.

The primary violation is the failure to develop, maintain, and follow an FSVP for any imported foods, including fresh "covered produce." This means the company did not demonstrate that its foreign suppliers produce food in compliance with U.S. food safety standards, specifically those under 21 CFR part 112 (Standards for Produce Safety). A Form FDA 483a FSVP Observations was issued, but no response has been received.

Additionally, La Sucursal Produce Inc. has not registered its facility with the FDA, a requirement under section 415 of the FD&C Act and 21 CFR part 1, subpart H. Failure to register is a prohibited act under section 301(dd) of the FD&C Act.

The FDA requires the company to register its facility within 30 working days and respond in writing within fifteen working days, detailing corrective actions, including a revised FSVP and implementation records. Failure to comply may result in refusal of admission for