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.
The U.S. Food and Drug Administration (FDA) has issued warning letters to several food importers for significant violations of the 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 highlight the importance of adhering to strict food safety standards to protect public health. Below are the details of the warning letters issued 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, based in Los Angeles, CA, following an inspection conducted from Feb. 21, 2024, through March 4, 2024. The inspection was triggered by 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’s inspection revealed 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. Additionally, the company had not registered their facility in Vernon, CA, as required under section 415 of the FD&C Act. At the conclusion of the inspection, FDA investigators provided the firm with a Form FDA 483a, FSVP Observations.
The FDA has requested the company to address these violations immediately. Failure to do so may result in the refusal 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., located in Elk Grove Village, Illinois, received a warning letter from the FDA on Aug. 5, 2024, following 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 follow an FSVP for various imported foods, including flour, kumis, seabuckthorn juice, and teas from foreign suppliers. At the conclusion of the inspection, FDA investigators provided the firm with a Form FDA 483a, FSVP Observations.
Despite previous inspections and warnings, Anglo Freight has not provided adequate documentation or corrective actions to address these violations. The FDA has warned that continued non-compliance may lead to the detention of their imported foods without physical examination.
The full warning letter can be viewed here.
Minland of Texas Inc.
Houston, TX
Minland of Texas, Inc., based in Houston, Texas, was issued a warning letter on July 23, 2024, after a remote FSVP inspection conducted on June 11-12, 2024. The inspection, along with previous ones in 2023, found that the company had not developed an FSVP for any of the foods they import, including peanut gluten, soy sauce, and rice vinegar from foreign suppliers. At the conclusion of the inspection, FDA investigators provided the firm with a Form a FDA 483a, FSVP Observations.
The FDA has demanded that Minland of Texas take immediate corrective actions to comply with FSVP regulations. Failure to respond may result in further enforcement actions, including the refusal of admission of their imported foods into the U.S.
The full warning letter can be viewed here.
La Parcela Produce LLC
Bloomington, MN
On July 16, 2024, the FDA issued a warning letter to La Parcela Produce LLC, located in Bloomington, MN, following an inspection from Feb. 28, 2024, through March 26, 2024. The inspection found that the company did not develop, maintain, or follow an FSVP for several imported foods, including cilantro, lettuce, and poblano peppers. At the conclusion of the inspection, FDA investigators provided the firm with a Form a FDA 483a, FSVP Observations.
The company’s response to the FDA’s observations included terminating relationships with some foreign suppliers who failed to provide verification activities. However, the FDA noted that La Parcela Produce LLC did not provide corrective actions for all imported foods, nor did they establish and follow written procedures for ensuring appropriate foreign supplier verification activities.
The full warning letter can be viewed here.
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