As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some warning letters are not made public until weeks or months after they are sent. Employers must respond to FDA warning letters within 15 days. Warning letters are often not issued until companies have had months or even years to correct the problem.
J&R Produce Co., Ltd.
Houston, Texas
The FDA has warned a Texas food company about violations of Foreign Supplier Verification Program (FSVP) regulations.
The FSVP regulations require importers to perform certain risk-based activities to ensure 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 its May 28, 2024, warning letter, FDA described an FSVP inspection conducted on March 13-14, 2024 at J&R Produce Inc., located in Houston, Texas.
At the conclusion of the inspection, the FDA investigator provided the company with an FDA 483a FSVP Observation Form.
Some of the serious violations of FSVP regulations are:
Your business has failed to develop, maintain, and comply with an FSVP as required. Specifically, you have failed to develop an FSVP for any of the foods you import, including the following foods:
Serrano peppers, husk tomatoes, and jalapeño peppers are located in (REDACTED BY FDA) and (REDACTED BY FDA).
During the FDA inspection, the company submitted an audit certificate for (redacted by FDA), which listed it as a packing plant operation. A foreign supplier of food is a facility that manufactures/processes food and raises or grows animals for export to the United States, and where no further manufacturing/processing takes place by another facility, except for further manufacturing/processing consisting solely of the addition of a label, or activities of a similar de minimis nature. According to documentation submitted to FDA, the foreign supplier of Serrano Peppers, Husk Tomatoes, and Jalapeños is (redacted by FDA), located at (redacted by FDA). However, this company did not submit any FSVP documentation applicable to your foreign suppliers, as required.
Your business imports fresh produce that is “covered produce.” As an importer of covered produce, you must obtain an FSVP to demonstrate that your suppliers are producing the food in compliance with processes and procedures, and implementing regulations, that provide a level of public health protection at least equal to that required by the standard for growing, harvesting, packing, and holding edible produce.
The full warning letter can be read here.
AKT Trading Co., Ltd.
Torrance, California
The FDA has warned a California food company about violations of Foreign Supplier Verification Program (FSVP) regulations.
The FSVP regulations require importers to perform certain risk-based activities to ensure 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 its June 10, 2024, warning letter, FDA described FSVP inspections to be conducted on November 6 and 13, 2023, and December 15, 2023, at AKT Trading Inc., Torrance, California.
At the conclusion of the inspection, the FDA investigator provided the company with an FDA 483a FSVP Observation Form.
Some of the serious violations of FSVP regulations are:
1. As part of the company’s evaluation of foreign supplier performance and the risks posed by foods, including approval of foreign suppliers and determining the appropriate supplier verification activities that must be conducted with foreign suppliers for the types of foods imported, the company failed to consider the foreign supplier’s performance, including applicable FDA food safety regulations, as required for the evaluation.
According to documents submitted to the FDA, cooked bamboo shoot products manufactured by (redacted by FDA) are acidic foods. However, the company’s FSVP did not include documentation that addressed whether the supplier complies with applicable FDA food safety regulations, such as those for acidic foods, which may include submitting to FDA a scheduled process for controlling biological hazards identified in the hazard analysis.
2. The firm did not meet the requirements to conduct required foreign supplier verification activities. Specifically, the firm did not develop written procedures to ensure that appropriate supplier verification activities were being conducted and did not document the determination of appropriate supplier verification activities or the frequency with which the required activities were conducted. During the FDA inspection, the firm submitted FSVPs for (redacted by FDA) processed enoki mushroom (also known as nametake) products, (redacted by FDA) processed shiitake mushrooms, and (redacted by FDA) dried enoki mushrooms. The submitted FSVP documentation included copies of each supplier’s approval documentation and the supplier’s food safety plans, but did not include documentation of the determination of appropriate supplier verification activities or the frequency with which the required activities were conducted.
The full warning letter can be read here.
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