# FDA WARNING_LETTER - Chula Vista Imports Ltd. - April 22, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/chula-vista-imports-ltd/946eb4bb-6ae7-4fab-93e7-e8e006b245c9

> FDA WARNING_LETTER for Chula Vista Imports Ltd. on April 22, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Chula Vista Imports Ltd.
- Inspection Date: 2021-04-22
- Product Type: Food
- Office Name: Division of Northern Border Imports
- Summary: 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

## Related Officers

- [Keith Jasukaitis](https://www.globalkeysolutions.net/people/keith-jasukaitis/0944ea7d-e874-476a-94ed-07905d2788c4)

Company: https://www.globalkeysolutions.net/companies/chula-vista-imports-ltd/689e526c-4224-48da-af09-284db39a04da

Office: https://www.globalkeysolutions.net/offices/division-of-northern-border-imports/935a3abc-aed7-478d-bfd8-c88c8050b57e