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Navigating FSVP Compliance: Insights from Recent FDA Inspection News

Kari-Fresh LLC

2501 Lott Road, Donna, TX

In June 2023, the Food and Drug Administration (FDA) conducted a thorough inspection under the Foreign Supplier Verification Program (FSVP) at Kari-Fresh LLC, situated at 2501 Lott Rd., Donna, TX 78537. A prior inspection occurred from January 21, 2021, to March 11, 2021. These inspections aimed to assess compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 805 and the corresponding FSVP regulation in 21 CFR part 1 subpart L.

The FSVP regulation mandates importers to conduct risk-based activities ensuring that imported human and/or animal food complies with applicable U.S. food safety standards.

During the latest inspection, the FDA identified non-compliance with the requirements of 21 CFR part 1 subpart L concerning the imported foods. Due to these significant violations, the company is found to be in non-compliance with FD&C Act Section 805.

Upon completing the inspection, the FDA provided Kari-Fresh LLC with a Form FDA 483a, FSVP Observations. Although the company submitted a written response on September 8, 2023, requesting a six-month extension and mentioning the engagement of a consultant, the FDA cannot assess the adequacy of the response due to the lack of supporting documents or details on corrective actions. To date, no additional FSVP documents have been received by the FDA.

The major violation of the FSVP regulation is outlined as follows:

Failure to develop, maintain, and follow an FSVP, as required by FD&C Act Section 805 and 21 CFR 1.502(a). Specifically, an FSVP was not developed for any imported foods, including:

Fresh Cilantro imported from (b)(4)

Fresh Persian Limes imported from (b)(4)

Fresh Green Onions imported from (b)(4)

As an importer of covered produce, the company is obligated to have an FSVP demonstrating that its supplier adheres to processes ensuring a level of public health protection equivalent to that required under FD&C Act Section 419 and the corresponding regulations in 21 CFR part 112.

The listed violations are not exhaustive, and it is the company's responsibility to ensure compliance with FD&C Act Section 805 and 21 CFR part 1, subpart L.

Failure to adequately address these concerns may prompt the FDA to take further action, including refusing admission of the implicated food imports or placing them on detention without physical examination (DWPE) upon entry into the United States.

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