The FDA issues warning letters to businesses under its jurisdiction as part of its enforcement activities, with business owners given 15 days to respond. These letters are often made public weeks or months after being sent, following a period where companies are given time to address identified problems.
Recently, Greenfruit Avocados LLC and Key Foods Co. have received such letters for violations of the Foreign Supplier Verification Program (FSVP) regulations.
Greenfruit Avocados LLC, an importer of avocados, received a warning letter on July 8, 2024, after multiple inspections revealed serious FSVP violations. The company failed to properly evaluate and approve its foreign suppliers based on risk assessments and did not establish written procedures for importing foods from approved suppliers.
The inspections found that Greenfruit only considered packers as suppliers, neglecting the actual growers, thus violating FSVP regulations.
The key violations for Greenfruit included not approving foreign suppliers based on comprehensive evaluations and lacking written procedures to ensure imports from approved suppliers.
Despite having an FSVP Standard Operating Procedure (SOP), the company did not follow these procedures, limiting evaluations to packing houses instead of growers. The FDA has demanded corrective actions from Greenfruit, requiring documentation of revised procedures and compliance efforts.
Similarly, Key Foods Co., operating as Key Food Services, received a warning letter on June 27, 2024, for significant FSVP violations. Inspections revealed that the company did not develop, maintain, or follow an FSVP for any imported foods.
This included several products such as Oliang Powder Mixed, Rice Stick Noodles, Thai Hom-Mali Rice, and Coconut Milk, indicating a failure to perform risk-based activities necessary to ensure food safety.
The FDA has required Key Foods Co. to take immediate corrective actions, providing documentation of the development and implementation of FSVPs for all imported foods.
Both companies face potential further enforcement actions, including the refusal of admission of imported foods into the U.S. market, unless they can demonstrate compliance with FSVP regulations.
The full warning letters for both Greenfruit Avocados LLC and Key Foods Co. highlight the importance of adhering to regulatory standards to ensure food safety.
