FDA issues warning to Jalisco Fresh Produce for import violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Jalisco Fresh Produce Inc.
Los Angeles, CA

The U.S. Food and Drug Administration has issued a warning letter to Jalisco Fresh Produce Inc., located at 1601 E Olympic Blvd. Bldg. #100, Los Angeles, CA, for significant violations of the Foreign Supplier Verification Program (FSVP). The letter, dated June 11, follows inspections conducted on Feb. 24, 2025, and previously on Nov. 30–Dec. 16, 2020, and Oct. 7–14, 2022.

The FSVP regulation requires importers to verify that food imported into the United States meets U.S. safety standards, ensuring conditions equivalent to domestic regulatory requirements. The FDA found that Jalisco Fresh Produce failed to develop, maintain or follow an FSVP for multiple imported food products.

Inspection findings
During the February 2025 inspection, FDA investigators determined that Jalisco Fresh Produce did not have an FSVP in place for several imported foods, including:

• Jalapeno Pepper from a supplier in an undisclosed location
• Jalapeno Pepper from another supplier in an undisclosed location
• White Onions from a supplier in an undisclosed location

The inspection revealed that the company failed to comply with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation in 21 CFR part 1, subpart L. Specifically, the firm did not develop an FSVP for any of the foods it imports, including fresh produce that may be considered “covered produce” under 21 CFR 112.3. If classified as covered produce, these foods require verification that suppliers meet standards for produce safety under section 419 of the FD&C Act.

At the conclusion of the inspection, the FDA issued a Form FDA 483a outlining the violations. The company responded on March 6, 2025, stating it would hire a third party to assist with its FSVP. However, the FDA found the response inadequate, as it lacked supporting documentation to demonstrate corrective actions.

FDA’s concerns
The FDA emphasized that Jalisco Fresh Produce’s failure to comply with FSVP regulations could allow unsafe food to enter the U.S. market. The agency warned that continued noncompliance may lead to further enforcement actions, such as refusal of admission for the implicated products or placement on detention without physical examination under Import Alert #99-41. Additionally, importing food without a compliant FSVP is a prohibited act under federal law.

The full warning letter can be viewed here.

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