Chula Vista Imports Ltd. – FDA Warning Letter, Apr 22, 2021
On April 15-22, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Chula Vista Imports Ltd. at 2541 S. Damen Ave, Unit A, Chicago, IL. This inspection, following a previous one on July 11, 2019, aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers to perform risk-based activities to ensure imported food meets U.S. safety standards.
The inspection revealed significant non-compliance: Chula Vista Imports Ltd. failed to develop, maintain, and follow an FSVP for any imported foods, including frozen strawberries from Productores Agricolas de Jacona (Mexico), frozen mango cubes, and chocolate-flavored coating. This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act.
The FDA issued a Form FDA 483a, FSVP Observations, on April 22, 2021, to which no response was received. Failure to adequately address these violations may lead to further action, including refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of
ID · 946eb4bb-6ae7-4fab-93e7-e8e006b245c9
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.