Companies in California, Florida, New York and Texas warned about import violations

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.

Triple J Fresh LLC
Hidalgo, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an April 25, warning letter, the FDA described a Jan. 6-7 Foreign Supplier Verification Program (FSVP) inspection of Triple J Fresh in McAllen, 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. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods, including each of the following foods:

• Fresh broccoli and fresh coriander imported from (redacted), located in (redacted)
• Fresh Persian limes imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

El Dorado Imports Inc.
Houston, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an April 26 warning letter, the FDA described a Dec. 9-17, 2021, Foreign Supplier Verification Program (FSVP) inspection of El Dorado Imports Inc. in Spring, 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. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following food products:

• Coconut candy imported from (redacted)
• Sugar baked flour tortillas imported from (redacted)
• Sweet bread with pineapple imported from (redacted)

The full warning letter can be viewed here.

Lempira Distribution LLC
Miami, FL

An import company in Florida is on notice from the FDA for not having FSVPs for a number of imported food products.

In a Nov. 3 warning letter, the FDA described a June 9 through July 16, 2021, Foreign Supplier Verification Program (FSVP) inspection of Lempira Distribution LLC in Miami, FL.

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. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP  for the food products that they import, including, but not limited to:

• Banana Soft Drink, imported from (redacted), located in (redacted)
• Sweet Bread, imported from (redacted), located in (redacted)
• (Redacted) Plantain Chips, imported from (redacted)

The full warning letter can be viewed here.

LECS USA Inc.
Los Angeles, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a March 28 warning letter, the FDA described a Nov. 10, 2021, Foreign Supplier Verification Program (FSVP) inspection of LECS USA Inc. in Los Angeles, 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. The significant violations are as follows:

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

• (Redacted) Green Tea imported from foreign suppliers, (redacted)

The full warning letter can be viewed here.

Fres Co. LLC
Bronx, NY

An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.

In an April 18 warning letter, the FDA described a Dec. 7, 2021, through Jan. 24, 2022, Foreign Supplier Verification Program (FSVP) inspection of Fres Co. LLC in Bronx, NY.

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. The significant violations are as follows:

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

• Fresh plantains from (redacted)
• Fresh mangoes from (redacted)
• Tomatoes from (redacted)

The full warning letter can be viewed here.

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