2501 Lott Road, Donna, TX
On June 26 through June 28, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Kari-Fresh LLC located at 2501 Lott Rd., Donna, TX 78537. The agency also conducted an inspection on Jan. 21, 2021, through March 11, 2021. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
During the most recent inspection, the FDA found that the company was not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of these significant violations, the company is not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, an FDA investigator provided the company with a Form FDA 483a, FSVP Observations. The FDA acknowledges the company’s written response dated, Sept. 8, 2023, in which it stated that it is requesting an additional six month extension, as it has hired a consultant. The FDA is unable to evaluate the adequacy of the company’s response because it has not provided any documents or additional details demonstrating planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.
The significant violation of the FSVP regulation is as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including the following foods:
• Fresh Cilantro imported from (b)(4)
• Fresh Persian Limes imported from (b)(4)
• Fresh Green Onions imported from (b)(4)
The company’s import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, the company must have an FSVP that demonstrates that its supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is the company’s responsibility to ensure that it is in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
If the company does not adequately address this matter, the FDA may take further action. For instance, it may refuse admission of the food the company imports for which it appears to be in violation of section 805. The FDA may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods.
The full warning letter can be read by clicking here.