The FDA sends warning letters to two companies over import safety violations

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often only issued after a company has been given months or years to resolve problems.

Greenfruit Avocados LLC
Newport Beach, CA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenfruit Avocados LLC for serious violations of Foreign Supplier Verification Program (FSVP) regulations. The letter was issued on July 8, 2024 following multiple inspections, the most recent of which took place from January 16 to 18, 2024 at the company’s facility in Newport Beach, California.

Greenfruit Avocados, LLC imports avocados into the United States. The FDA’s inspection found significant deficiencies in the company’s compliance with FSVP regulations, which are intended to ensure that imported foods meet U.S. safety standards. These violations include failure to properly assess and approve foreign suppliers based on risk assessments and failure to establish and follow written procedures for importing foodstuffs from approved suppliers. At the end of the inspection, FDA investigators provided the company with an FDA 483a FSVP Observations form.

Main violations:

1. Lack of proper approval from the supplier:
   • Greenfruit Avocados has not approved its foreign suppliers based on a comprehensive evaluation of the supplier’s performance and the risks posed by the food, as required. In particular, the company failed to evaluate the performance of the growers from which the avocados came.
   • The company considered only the packers as their suppliers and failed to recognize that the actual foreign suppliers, according to FSVP regulations, are the growers of the avocados. Packers perform minimal processing activities and do not qualify as foreign suppliers under the scheme.
2. Failure to establish and follow written procedures:
   • The company did not have written procedures in place to ensure that they only imported food from approved foreign suppliers, especially from the growers. This omission is a violation of the regulations.
   • Despite submitting an FSVP Standard Operating Procedure (SOP) outlining review and approval processes, Greenfruit Avocados did not follow these procedures to ensure compliance. The evaluations carried out were limited to the warehouses and did not extend to the growers.

FDA Response and Requirements
The FDA has requested that Greenfruit Avocados address these significant violations by proposing detailed corrective actions. The company must provide documentation demonstrating that FSVP procedures have been revised, records of grower evaluations and approvals, and any additional information demonstrating compliance with FSVP regulations.

Failure to adequately address these issues could result in further enforcement actions, including denial of admission of imported food into the United States and detention without physical examination (DWPE). This would effectively prevent Greenfruit Avocados products from entering the US market until the company can demonstrate compliance.

You can view the full warning letter here.

Key Foods Co. dba Key Food Services
Alsip, IL

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Key Foods Co., operating as Key Food Services, for significant violations of Foreign Supplier Verification Program (FSVP) regulations. The letter, dated June 27, 2024, follows inspections conducted at the company’s Alsip, Illinois facility from April 11 to April 25, 2024 and April 3 to 17, 2023.

Key Foods Co. imports various food products into the United States. The FDA’s inspection found that the company failed to develop, maintain, and follow an FSVP for the foods it imports, as required by Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C act). At the end of the inspection, FDA investigators provided the company with an FDA 483a FSVP Observations form.

Main violations:

1. Failure to develop and maintain an FSVP:
   • Key Foods Co. has not developed an FSVP for several imported food products, including Oliang Powder Mixed (Café Gu Cua Thai Lan), Rice Stick Noodles, Thai Hom-Mali Rice and Coconut Milk.
   • The lack of an FSVP means that the company has not conducted the necessary risk-based activities to verify that these foods meet U.S. safety standards.

FDA Response and Requirements
The FDA has ordered Key Foods Co. requested to take immediate corrective action. The company must provide documentation demonstrating the development and implementation of FSVPs for all imported foods. This includes documents demonstrating compliance with FSVP requirements and any additional information that supports the company’s efforts to meet regulatory standards.

You can view the full warning letter here.

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