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 FDA has issued warning letters to two produce importers, Future Best Trading Inc. and Paso Real Produce LLC, for major violations under the Foreign Supplier Verification Program (FSVP). Both firms received a Form FDA 483a, detailing their serious compliance lapses.
Future Best Trading Inc.
Temple City, CA
Located in Temple City, CA, Future Best Trading was cited on Oct. 10, for failing to develop a compliant FSVP for Enoki and King Oyster Mushrooms imported from multiple suppliers. A recent FDA inspection triggered by findings of Listeria monocytogenes in a mushroom sample highlighted the company’s lack of safety protocols to evaluate supplier risks and monitor hazard control. Though the company provided some records, FDA noted that these documents lacked clarity and approval by qualified FSVP personnel.
Violations:
- Lack of a comprehensive FSVP for imported mushrooms, including enoki and king oyster varieties.
- Multiple documents provided by the company were insufficient or lacked the necessary review by a qualified individual.
- Failure to demonstrate risk analysis or foreign supplier verification activities as required by FSVP regulations.
- Detection of Listeria monocytogenes in an enoki mushroom sample imported on May 6, 2024, led to product destruction under FDA supervision.
The full warning letter can be viewed here.
Paso Real Produce LLC
Pharr, TX
Paso Real Produce LLC, based in Pharr, TX, received an FDA warning letter on Oct. 1, 2024, because of repeat FSVP violations for imported avocados and limes. The company had previously been warned in inspections from 2021 and 2023, but failed to implement corrective actions. FDA emphasized that without compliance, Paso Real Produce could face import detentions and further regulatory actions.
Violations:
- Ongoing failure to establish and maintain an FSVP for produce such as avocados and limes from multiple suppliers.
- Repeat observations from 2021 and 2023 inspections showing no corrective actions implemented.
- Failure to ensure foreign suppliers meet U.S. produce safety standards, particularly for fresh produce that falls under FDA coverage.
The full warning letter can be viewed here.
(To sign up for a free subscription to Food Safety News, click here.)
