The FDA is warning Texas and California food companies about failing to verify foreign suppliers

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.

J&R Produce Inc.
Houston, Texas

The FDA has warned a Texas food company for violations of Foreign Supplier Verification Programs (FSVP) regulations.

The FSVP regulations require importers to conduct certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In a warning letter dated May 28, 2024, the FDA described a March 13-14, 2024 FSVP inspection of J&R Produce Inc. in Houston, Texas.

At the end of the inspection, the FDA investigator provided the company with an FDA 483a FSVP Observations form.

Some of the significant violations of the FSVP regulation are as follows:

The company has not developed, maintained, and tracked an FSVP as required. Specifically, they have not developed an FSVP for the foods you import, including the following foods:

• Serrano pepper, peel tomato and jalapeno pepper from (edited by FDA)located in (edited by FDA)

During the FDA inspection, they provided an audit certificate (edited by FDA), which is described on the audit certificate as a warehouse operation. A foreign supplier of a food item is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further production/processing by another establishment, except further production/processing that consists of : solely by the addition of labeling or any similar activity of a de minimis nature. Based on the documents they provided to the FDA, their foreign supplier of the serrano peppers, peel tomatoes, and jalapeno peppers (edited by FDA)located in (edited by FDA). However, as required, the company has not provided FSVP documents applicable to your foreign supplier.

The company imports fresh products that are ‘covered fruit’. As importers of products covered by the Directive, they must have an FSVP demonstrating that their supplier produces the food in accordance with processes and procedures that provide at least the same level of protection of public health as required and the implementing provisions in the Cultivation Standards , harvesting, packaging and storing products for human consumption.

You can view the full warning letter here.

AKT Trading Inc.
Torrance, CA

The FDA has warned a California food company for violations of Foreign Supplier Verification Programs (FSVP) regulations.

The FSVP regulations require importers to conduct certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In a warning letter dated June 10, 2024, the FDA described a November 6 and 13, 2023, and December 15, 2023 FSVP inspection of AKT Trading Inc. in Torrance, CA.

At the end of the inspection, the FDA investigator provided the company with an FDA 483a FSVP Observations form.

Some of the significant violations of the FSVP regulation are as follows:

1. As part of the company’s evaluation of a foreign supplier’s performance and the risk posed by a food product, as required, including approving their foreign suppliers and determining the appropriate supplier verification activities to be performed for a foreign supplier of a type of food product they are importing, they did not consider the foreign supplier’s performance, including applicable FDA food safety regulations, in an evaluation.

Based on documents provided to the FDA, the prepared bamboo shoot product is manufactured by (edited by FDA) is like an acidified food. However, their FSVP did not include documentation demonstrating that their supplier had complied with applicable FDA food safety regulations, such as those for acidified foods, which may include submitting to the FDA a planned process to control the biological hazards identified in their hazard risk identified. analysis.

2. The company did not comply with the requirement to carry out the required verification activities for foreign suppliers. In particular, they have not established written procedures to ensure that appropriate supplier verification activities are performed, and have not documented their determination of the appropriate supplier verification activity(s), or the frequency with which the activity(s) should be performed, as required. During the FDA inspection, they provided their FSVPs for processed enoki mushroom products (also called namtake mushrooms). (edited by FDA); processed shitake mushrooms from (edited by FDA) and dried enokitake mushrooms (edited by FDA). Although the FSVP documents they provide include documentation of their approval of each supplier and a copy of their supplier’s food safety plan, they do not include documentation of their determination of appropriate supplier verification activities or the frequency with which such activities should be performed as required. .

You can view the full warning letter here.

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