FDA WARNING_LETTER - Ocalsa Transport & Logistics, LLC - February 24, 2023

On June 22, 2023, the FDA issued a Warning Letter to Ocalsa Transport & Logistics, LLC following an FSVP inspection on February 23-24, 2023. 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 was the failure to develop, maintain, and follow an FSVP for any imported foods, including fresh "covered produce." As an importer of covered produce, Ocalsa Transport & Logistics, LLC is required to have an FSVP demonstrating that their suppliers meet U.S. food safety standards, specifically those in 21 CFR part 112 (Standards for Produce Safety). The company did not respond to the Form FDA 483a issued at the inspection's conclusion.

Additionally, the facility is not currently registered 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 Act.

Ocalsa Transport & Logistics, LLC must register their facility within 30 working days and respond in writing within 15 working days, detailing corrective actions, providing supporting documentation (e.g., a copy of their FSVP and implementation records),