As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. 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.
In recent warning letters, the U.S. Food and Drug Administration (FDA) cited multiple food companies for failing to meet critical food safety standards under the Foreign Supplier Verification Program (FSVP). These companies, including Pacific Exchange Distributors LLC, JC Finest Produce Inc., Green Day Produce, Troya Del Campo USA LLC, and JJH Trading Inc., were found in violation of section 805 of the Federal Food, Drug, and Cosmetic Act.
Pacific Exchange Distributors LLC
Long Beach, CA
Pacific Exchange Distributors, which imports seasoned radish strips, plums and mustard greens, was sent a warning letter on Sept. 12 for not maintaining and following an FSVP for most of its products. The FDA found that the company failed to conduct written hazard analyses or document proper supplier evaluations. At the conclusion of the FDA’s inspection of the firm, investigators provided the firm with a Form FDA 483a FSVP Observations. Furthermore, the company’s hazard analysis did not account for known food-related chemical hazards such as pesticides. The FDA emphasized the company’s failure to verify that foreign suppliers implemented adequate controls to ensure the safety of imported foods.
The full warning letter can be viewed here.
JC Finest Produce Inc.
Mesquite, TX
On June 24 JC Finest Produce Inc. received a warning for failing to develop an FSVP for imported produce such as Persian limes, rambutans and Thai bananas. Despite multiple inspections, the company had not implemented measures to verify that their foreign suppliers adhered to U.S. food safety standards.
At the conclusion of the most recant inspection, FDA investigators provided the firm with a Form FDA 483a, FSVP Observations. The FDA warned that continued non-compliance could result in the refusal of food imports or the detention of products without physical examination.
The full warning letter can be viewed here.
Green Day Produce, Inc.
Vernon, CA
Green Day Produce, which imports seafood mushrooms, oyster mushrooms and Taiwanese mangos, was issued a warning letter on July 11 The FDA found the company failed to evaluate its foreign suppliers’ performance and the risks posed by the foods it imports, as required by the Produce Safety Rule. At the conclusion of the inspection, an FDA investigator provided them with a Form FDA 483a, FSVP Observations. Although Green Day attempted corrective actions, the FDA found their efforts insufficient and emphasized the need for stronger verification activities.
The full warning letter can be viewed here.
Troya Del Campo USA LLC
McAllen, TX
Troya Del Campo USA LLC was cited on Sept. 4 for significant failures in its FSVP, particularly for fresh produce imports such as avocados, cilantro and broccoli. Despite two inspections, the company had not implemented an FSVP that ensures imported foods meet U.S. safety standards. At the conclusion of the most recent inspection, an FDA investigator provided them with a Form FDA 483a FSVP Observations. The FDA stressed that without compliance, Troya Del Campo’s imports could face detention without physical examination.
The full warning letter can be viewed here.
JJH Trading Inc.
El Monte, CA
On Sept. 11 JJH Trading Inc. was warned for not developing or maintaining an FSVP for foods such as broad beans, crushed chili, nut snacks and dehydrated mango slices. The company failed to conduct required risk evaluations for its foreign suppliers and did not respond to the FDA’s inspection observations. At the conclusion of the FDA’s inspection of the firm, an FDA investigator provided them with a Form FDA 483a FSVP Observations. The FDA urged the company to comply with FSVP regulations or risk having their imported foods refused entry into the U.S.
The full warning letter can be viewed here.
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