FDA Issues Warning to Produce Importer for Non-Compliance

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

Between April 26 and May 1, 2023, the Food and Drug Administration (FDA) carried out an inspection under the Foreign Supplier Verification Program (FSVP) at the premises of Ikal, Llc., situated at 8766 Sherwood Terrace, San Diego, CA. This was preceded by a prior inspection conducted from May 14 to May 20, 2021. The objective of these inspections was to assess the company's adherence to the stipulations of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the associated FSVP regulation outlined in 21 CFR part 1, subpart L.

The FSVP regulation necessitates that importers undertake specific risk-based procedures to confirm that the human and/or animal food they import into the United States complies with relevant U.S. food safety standards.

During the most recent inspection, the FDA identified instances of non-compliance by the company with the requirements specified in 21 CFR part 1, subpart L, for the imported food items. These substantial violations render the company non-compliant with section 805 of the FD&C Act.

At the conclusion of the inspection, the FDA investigator provided Ikal, Llc. with Form FDA 483a, outlining FSVP Observations. The FDA duly received the company's written response, dated May 2, 2023. In the response, the company explained that it had engaged a consultant before the latest inspection, believing it had already established an FSVP for avocados. However, it was discovered that the FSVP was incomplete. In response, the company committed to enrolling in an FSVP course in June, re-establishing contact with the aforementioned consultant, and evaluating whether it needed to appoint an FSVP agent.

Ikal, Llc. requested a six-month extension to rectify its FSVP. Subsequently, on May 11, 2023, the FDA received the company's response along with an invoice for an FSVP course. A subsequent email dated July 3, 2023, included a copy of the company's Certificate of Training for FSVP, issued on June 16, 2023, by the Food Safety Preventive Controls Alliance (FSPCA).

However, the FDA is unable to assess the adequacy of the company's responses because, except for the Certificate of Training for FSVP, no supporting documentation demonstrating planned or executed corrective actions has been furnished. As of the present date, the FDA has not received any additional FSVP-related documents.

Notable violations of the FSVP regulation include:

1. Failure to create, uphold, and abide by an FSVP, as mandated by section 805 of the FD&C Act and 21 CFR part 1.502(a). The company did not establish an FSVP for any of the food items it imports, which includes various types of fresh avocados.

2. As an importer of covered produce, the company imported fresh produce falling under the category of "covered produce" as described in 21 CFR 112.3. In this role, the company must maintain an FSVP demonstrating that its suppliers adhere to procedures and processes that offer a level of public health protection equivalent to that stipulated under section 419 of the FD&C Act (21 U.S.C. § 350h) and the associated regulations contained in 21 CFR part 112, which concern standards for produce safety.