The FDA uses warning letters to enforce compliance with regulations for regulated entities. These letters might not be publicly available for weeks or months following their issuance. Companies are given a 15-day window to respond, with the letters typically being sent only after the company has had an extended period—ranging from months to years—to resolve the issues.
Recently, the FDA issued a warning letter to Greenfruit Avocados LLC based in Newport Beach, California, on July 8, 2024. This action followed several inspections, the latest of which occurred from January 16-18, 2024.
The warning letter highlighted serious violations of the Foreign Supplier Verification Program (FSVP) regulations, which ensure that imported foods meet U.S. safety standards. Specifically, the FDA found that Greenfruit Avocados failed to properly evaluate and approve foreign suppliers and did not establish or adhere to written procedures for importing foods from these suppliers.
The key violations identified for Greenfruit Avocados included a lack of proper supplier approval and failure to establish written procedures. The company did not comprehensively evaluate the performance of its avocado growers, focusing only on packers, which is insufficient under FSVP regulations.
Additionally, Greenfruit Avocados did not have written procedures to ensure compliance with FSVP requirements and did not follow their own outlined procedures for evaluating suppliers.
In response, the FDA has requested Greenfruit Avocados to submit detailed corrective actions, including revised FSVP procedures and records of supplier evaluations.
If the company fails to address these issues adequately, it may face further enforcement actions, such as refusal of admission of its products into the U.S. market or detention without physical examination, which would prevent its products from being imported until compliance is demonstrated.
Similarly, Key Foods Co., operating as Key Food Services in Alsip, Illinois, received a warning letter from the FDA on June 27, 2024, following inspections conducted in April 2024 and April 2023. The FDA found that Key Foods Co. had failed to develop, maintain, and follow an FSVP for several imported food products.
This omission means the company did not perform the necessary risk-based activities to verify that these foods met U.S. safety standards. The FDA has required Key Foods Co. to take corrective actions by developing and implementing FSVPs for all imported foods and providing documentation to demonstrate compliance with FSVP requirements.
