La Ilusion Fresh Guava Inc.

Warning LetterClosed

Mr. Javier Serna Flores La Ilusion Fresh Guava Inc. 5100 Tomcin Trl. Oak Lawn , IL 60453-5056 United StatesFEI 3014743216Issued May 12, 2022Division of Northern Border Imports

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014743216.

Violations3

Issue DateMay 12, 2022

Product TypeOther

StatusClosed

Closeout LetterMar 14, 2023

Letter Details

Firm: La Ilusion Fresh Guava Inc.
Location: Mr. Javier Serna Flores La Ilusion Fresh Guava Inc. 5100 Tomcin Trl. Oak Lawn , IL 60453-5056 United States
FEI Number: 3014743216
Country: United States
Issue Date: May 12, 2022
Issuing Office: Division of Northern Border Imports
Product Type: Other
Status: Closed
Closeout Letter: March 14, 2023

Summary

La Ilusion Fresh Guava Inc., an importer of fresh guava, fresh pitaya, and dragon fruit, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required under Section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart L. During a March 4, 2022 inspection, the FDA found that the company had not established any FSVP for the imported foods, despite being required to perform risk-based activities to verify that their products met applicable U.S. food safety standards. The company also failed to respond to a Form FDA 483a issued at the conclusion of the inspection.

La Ilusion Fresh Guava Inc. FDA Warning Letter, May 12, 2022