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.

J&R Produce Inc.
Houston, TX

The FDA has warned a food firm in Texas about violations of the Foreign Supplier Verification Programs (FSVP) regulation.

The FSVP regulation requires that importers perform 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 May 28, 2024 warning letter, the FDA described a March 13-14, 2024, FSVP inspection of J&R Produce Inc. in Houston, TX.

At the conclusion of the inspection, the FDA investigator provided the firm with a Form FDA 483a FSVP Observations.

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

The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods that you import, including the following foods:

• Serrano Pepper, Husk Tomato, and Jalapeno Pepper from (redacted by FDA), located in (redacted by FDA)

During FDA inspection they provided an audit certificate for (redacted by FDA), which is described as a packing house operation on the audit certificate. A foreign supplier of an article of food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. based on the documents they provided to FDA, their foreign supplier of the serrano peppers, husk tomato, and jalapeno peppers is (redacted by FDA), located in (redacted by FDA). However, the firm did not provide any FSVP documents that apply to your foreign supplier, as required.

The firm imports fresh produce that is “covered produce.” As an importer of covered produce, they must have an FSVP that demonstrates that their supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

The full warning letter can be viewed here.

AKT Trading Inc.
Torrance, CA

The FDA has warned a food firm in California about violations of the Foreign Supplier Verification Programs (FSVP) regulation.

The FSVP regulation requires that importers perform 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 June 10, 2024 warning letter, the FDA described a Nov. 6 and 13, 2023, and Dec. 15, 2023, FSVP inspection of AKT Trading Inc. in Torrance, CA.

At the conclusion of the inspection, the FDA investigator provided the firm with a Form FDA 483a FSVP Observations.

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

1. As part of the firm’s evaluation of a foreign supplier’s performance and the risk posed by a food, as required, which includes approving their foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food they import, they did not consider the foreign supplier’s performance including the applicable FDA food safety regulations as required for an evaluation.

based on documents provided to FDA, the prepared bamboo shoot product manufactured by (redacted by FDA) is as an acidified food. However, their FSVP did not include documentation that they considered whether their supplier had complied with the applicable FDA food safety regulations, such as the regulations for acidified foods, which may include filing with FDA a scheduled process to control the biological hazards identified in their hazard analysis.

2. The firm did not meet the requirement to perform foreign supplier verification activities as required. Specifically, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted, and they did not document their determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required. During FDA inspection, they provided their FSVPs for processed enoki mushroom (also called nametake mushrooms) products from (redacted by the FDA); processed shitake mushrooms from (redacted by the FDA) and dried enokitake mushrooms from (redacted by the FDA). While the FSVP documents they provided included documentation of their approval of each supplier and a copy of their supplier’s food safety plan, they did not include documentation of their determination of the appropriate supplier verification activities or frequency with which such activities must be conducted, as required.

The full warning letter can be viewed here.