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.
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Ikal LLC
San Diego, CA
On April 26 through May 1, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Ikal, Llc., located at 8766 Sherwood Terrace, San Diego, CA. The agency also conducted an inspection on May 14 through May 20, 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 is not in compliance with the requirements of 21 CFR part 1, subpart L for the foods it imports. 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, the FDA investigator provided the company with Form FDA 483a, FSVP Observations. The FDA has acknowledged receipt of the company’s written response, dated May 2, 2023. In the response the company stated that, prior to the most recent inspection, it had hired a consultant and thought it already had an FVSP for avocados, but found it was not complete. The company then said it would take an FSVP course in June, contact the consultant it already hired, and determine if it needed to hire someone to be its FSVP agent.
The company requested six months to complete its FSVP. On May 11, 2023, the FDA received the company’s response with an invoice for an FSVP course, followed by an email on July 3, 2023, with a copy of its Certificate of Training for FSVP, dated June 16, 2023, from the Food Safety Preventive Controls Alliance (FSPCA).
The FDA is unable to evaluate the adequacy of the company’s responses because, other than its Certificate of Training for FSVP, it has not provided any supporting documentation demonstrating of planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.
Significant violations of the FSVP regulation are as follows:
The company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, it did not develop an FSVP for any of the foods you import, including each of the following:
• Fresh avocados imported from (b)(4)
• Fresh avocados imported from (b)(4)
• Fresh avocados 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 complete warning letter can be viewed here.
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