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 warning letters from the FDA. Warning letters are often only issued after a company has been given months or years to resolve problems.
The U.S. Food and Drug Administration (FDA) has sent warning letters to several food importers for significant violations of Foreign Supplier Verification Program (FSVP) regulations. These violations have raised serious concerns about the safety and compliance of imported foods entering the U.S. market. The FDA’s actions emphasize the importance of adhering to strict food safety standards to protect public health. Below are details of the warning letters sent to HH Fresh Trading Corp, Anglo Freight USA Inc., Minland of Texas, Inc. and La Parcela Produce LLC.
HH Fresh Trading Corp.
Los Angeles, CA
On July 17, 2024, the FDA issued a warning letter to HH Fresh Trading Corp, located in Los Angeles, CA, following an inspection conducted from February 21, 2024 through March 4, 2024. The inspection was a result of FDA laboratory findings. of Listeria monocytogenes in a sample of fresh Enoki mushrooms imported by the company from a foreign supplier in South Korea.
The FDA inspection found that HH Fresh Trading Corp failed to develop, maintain and follow an FSVP for the fresh produce they import, including Enoki mushrooms, seafood mushrooms and bamboo shoots. In addition, the company had not registered its facility in Vernon, CA, as required under Section 415 of the FD&C Act. At the end of the inspection, FDA investigators presented the company with an FDA 483a, FSVP Observations form.
The FDA has requested that the company immediately address these violations. Failure to do so may result in denial of admission of their imported foods into the United States and other enforcement actions.
The full warning letter can be viewed here.
Anglo Freight USA Inc.
Elk Grove Village, IL
Anglo Freight USA Inc., based in Elk Grove Village, Illinois, received a warning letter from the FDA on August 5, 2024, after multiple inspections, including the most recent from May 20, 2024 through July 1, 2024. The inspections revealed that Anglo Freight failed to develop, maintain and monitor an FSVP for several imported foodstuffs, including flour, kumi, sea buckthorn juice and tea from foreign suppliers. At the end of the inspection, FDA investigators presented the company with an FDA 483a, FSVP Observations form.
Despite previous inspections and warnings, Anglo Freight has not provided adequate documentation or corrective action to address these violations. The FDA has warned that continued noncompliance could result in the detention of imported foods without a physical examination.
The full warning letter can be viewed here.
Minland of Texas Inc.
Houston, Texas
Minland of Texas, Inc., located in Houston, Texas, was issued a warning letter on July 23, 2024, following an FSVP remote inspection conducted on June 11-12, 2024. The inspection, along with previous inspections in 2023, revealed that it company had not developed an FSVP for the foods they import, including peanut gluten, soy sauce and rice vinegar from foreign suppliers. At the end of the inspection, FDA investigators presented the company with an FDA 483a, FSVP Observations form.
The FDA has required Minland of Texas to take immediate corrective action to comply with the FSVP regulations. Failure to respond may result in further enforcement action, including denial of admission of their imported foods into the U.S.
The full warning letter can be viewed here.
La Parcela Produce LLC
Bloomington, Minnesota
On July 16, 2024, the FDA issued a warning letter to La Parcela Produce LLC, located in Bloomington, MN, following an inspection from February 28, 2024 through March 26, 2024. The inspection found that the company was not developing, maintaining or following an FSVP for several imported foods, including cilantro, lettuce and poblano peppers. At the end of the inspection, FDA investigators presented the company with an FDA 483a, FSVP Observations form.
The company’s response to the FDA’s observations included terminating relationships with some foreign suppliers that had not performed verification activities. However, the FDA noted that La Parcela Produce LLC did not take corrective action on all imported foods, nor did it establish and follow written procedures to ensure appropriate verification activities of foreign suppliers.
The full warning letter can be viewed here.
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