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.
Jerez Produce, Inc.
Chicago, IL
An import company in Chicago is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 11, 2023, warning letter, the FDA described a Feb. 2-28, 2023, Foreign Supplier Verification Program (FSVP) inspection of Jerez Produce, Inc. in Chicago, Illinois.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations 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 they import, including each of the following foods:
- Fresh jalapeno peppers from (redacted), located in (redacted)
- Fresh epazote from (redacted), located in (redacted)
- Prickly pear imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Maos Produce
San Diego, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an May 30, 2023, warning letter, the FDA described a March 8, 2023, Foreign Supplier Verification Program (FSVP) inspection of Maos Produce in San Diego, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations 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 they import, including each of the following foods:
- Tomatoes imported from foreign supplier (redacted), located in (redacted)
- Fresh Persian Limes imported from foreign supplier (redacted), located in (redacted)
- Fresh Jalapeno Peppers imported from foreign supplier (redacted), located in (redacted)
The full warning letter can be viewed here.
Fruits Tress Inc.
Pharr, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 21, 2023, warning letter, the FDA described an April 11 and 14, 2023, Foreign Supplier Verification Program (FSVP) inspection of Fruits Trees in Pharr, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations 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 they import, including each of the following foods:
- Fresh Watermelon imported from (redacted) located in Campeche, (redacted);
- Fresh Papaya imported from (redacted) located in (redacted); and
- Fresh Papaya imported from (redacted) located in (redacted)
The full warning letter can be viewed here.
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