ISPE Produce Inc. – FDA Warning Letter, Feb 29, 2024

On April 23, 2024, the FDA issued a Warning Letter to ISPE Produce, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on February 29, 2024, and a previous inspection from July 6-10, 2023. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandate risk-based activities for importers to verify foreign food safety standards.

The FDA found significant violations, specifically that ISPE Produce, Inc. failed to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the firm did not demonstrate that its suppliers produce food in compliance with public health protection standards equivalent to those required under Section 419 of the FD&C Act and 21 CFR Part 112 (Standards for Produce Safety).

A Form FDA 483a FSVP Observations was issued on February 29, 2024, to which no response has been received. Failure to adequately address these violations may lead to further FDA action, including refusal of admission of imported food under Section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-