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.
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 the 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 Jan. 16-18, 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 lapses in the company’s compliance with FSVP regulations, which are designed to ensure that imported foods meet U.S. safety standards. These violations include failing to properly evaluate and approve foreign suppliers based on risk assessments and failing to establish and follow written procedures for importing foods from approved suppliers. At the conclusion of the inspection, FDA investigators provided the firm with a Form FDA 483a FSVP Observations.
Key violations:
- Lack of proper supplier approval:
- Greenfruit Avocados did not approve its foreign suppliers based on a comprehensive evaluation of the supplier’s performance and the risks posed by the food, as required. Specifically, the company failed to evaluate the performance of the growers from whom the avocados were sourced.
- The company considered only the packers as their suppliers, neglecting to recognize that the actual foreign suppliers, per FSVP regulations, are the growers of the avocados. Packers perform minimal processing activities and do not qualify as foreign suppliers under the regulation.
- Failure to establish and follow written procedures:
- The company did not have written procedures to ensure that they import foods only from approved foreign suppliers, particularly the growers. This omission is a violation of regulation.
- Despite submitting an FSVP Standard Operating Procedure (SOP) outlining evaluation and approval processes, Greenfruit Avocados did not follow these procedures to ensure compliance. The evaluations conducted were limited to the packing houses and did not extend to the growers.
FDA’s response and requirements
The FDA has requested Greenfruit Avocados to address these significant violations by submitting detailed corrective actions. The company must provide documentation showing revised FSVP procedures, records of evaluations and approvals of growers, and any additional information that demonstrates compliance with FSVP regulations.
Failure to adequately address these issues may lead to further enforcement actions, including the refusal of admission of imported foods into the United States and detention without physical examination (DWPE). This would effectively block Greenfruit Avocados’ products from entering the U.S. market until the company can demonstrate compliance.
The full warning letter can be viewed 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 the Foreign Supplier Verification Program (FSVP) regulations. The letter, dated June 27, 2024, follows inspections conducted from April 11-25, 2024, and from April 3-17, 2023, at the company’s facility in Alsip, Illinois.
Key Foods Co. imports various food products into the United States. The FDA’s inspection revealed that the company failed to develop, maintain, and follow an FSVP for any of the foods it imports, as required by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). At the conclusion of the inspection, FDA investigators provided the firm with a Form FDA 483a FSVP Observations.
Key violations:
- Failure to Develop and Maintain an FSVP:
- Key Foods Co. did not develop 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 absence of an FSVP means the company has not performed necessary risk-based activities to verify that these foods meet U.S. safety standards.
FDA’s response and requirements
The FDA has requested Key Foods Co. to take immediate corrective actions. The company must provide documentation showing the development and implementation of FSVPs for all imported foods. This includes records demonstrating compliance with FSVP requirements and any additional information that supports the company’s efforts to meet regulatory standards.
The full warning letter can be viewed here.
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