FDA sends warnings to import companies not in compliance...

FDA sends warnings to import companies not in compliance with regulations

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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.


Fresh Imports International 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 a May 4, 2022 warning letter, the FDA described a Jan. 31 through Feb. 2, 2022, Foreign Supplier Verification Program (FSVP) inspection of Fresh Imports International LLC in Hidalgo, 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:

  • Fresh avocados imported from (redacted)
  • Fresh pineapples imported from (redacted)
  • Fresh avocados imported from (redacted)

The full warning letter can be viewed here.

Daxa Foods Inc. dba India Grocers

Edison, NJ

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

In a May 31, 2022 warning letter, the FDA described a March 14-17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Daxa Foods, Inc. dba India Grocers in Edison, NJ.

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:

Puffed Rice imported from (redacted) 

Rice Flour and Shredded Coconut imported from (redacted)

The full warning letter can be viewed here.

Export Guatemala Corporation

Lake Worth, 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 May 31, 2022 warning letter, the FDA described a Feb. 17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Export Guatemala Corporation in Lake Worth, 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 each of the following foods:

  • Cacao Paste, imported from (redacted)
  • Corn Chips, imported from (redacted)
  • Whole White Corn, imported from (redacted)

The full warning letter can be viewed here.

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