FDA WARNING_LETTER - Promex Distribution LLC - February 11, 2020

On April 13, 2020, the FDA issued a Warning Letter to Promex Distribution, LLC, following Foreign Supplier Verification Program (FSVP) inspections on August 23, 2018, and February 11, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The firm was found non-compliant for not developing, maintaining, and following FSVPs for imported carbonated mineral water and cornmeal from foreign supplier (b)(4). This violates section 805 of the FD&C Act. Form FDA 483a, FSVP Observations, was issued after both inspections, but no response was received.

Promex Distribution, LLC, must promptly correct these violations. Failure to do so may result in refusal of admission for the non-compliant products under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

A written response is required within fifteen working days, detailing corrective actions, including documentation like a copy of the FSVP and records of its implementation. If corrections cannot be completed within 15 days, an explanation and