Businesses in 4 states warn of import violations for a range of foods

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not displayed to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a business has been given months, if not years, to correct the issues. The FDA frequently writes portions of warning letters that are published in public view.


California Terra Garden Inc.
Commerce, California

A California import company has received an FDA notice for not having FSVP for a number of imported food products.

In a November 10 warning letter, the FDA described an inspection of the Foreign Supplier Verification Program (FSVP) from May 11 to June 8, 2021 of California Terra Garden Inc. in Commerce, California.

The FDA inspection found that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The company has not developed, maintained or monitored FSVP for any of the foods it imports, including the following foods:

  • More specifically, the company’s king oyster mushrooms imported from (redacted), enoki mushrooms imported from (redacted), and fresh sea mushrooms imported from (redacted), are raw agricultural products, but the assessment and approval of the company’s suppliers did not take into account the suppliers’ compliance with the requirements of the Produce Safety Rule.
  • The company’s response to FDA 483a, dated June 22, 2021, indicates that it has suspended and canceled orders from its suppliers of enoki and sea mushrooms and that it intends to “”[r]review the supplier approval process, impose tighter control and perform more testing. The FDA is unable to review the adequacy of its response because it did not describe how it would determine whether its suppliers are producing food in accordance with the Produce Safety Rule. The company also did not provide information regarding its review of product safety-related processes and procedures for its suppliers of other imported covered products, such as oyster mushrooms.
  • The company’s supplier verification activities have not provided sufficient assurance that hazards requiring control in the food they import have been significantly reduced or avoided. The FDA has determined that biohazards in covered products require control, and meeting the requirements of the Produce Safety Rule significantly minimizes or prevents biohazards. However, their verification activities did not include verifying their suppliers’ compliance with the product safety rule or documenting processes or procedures that provide at least the same level of public health protection as required by the product safety rule.

The FSVP requires importers to verify that their foreign suppliers of food and feed meet applicable FDA safety standards.

The full warning letter can be viewed here.

Distribution Bella Rosa inc.
Minneapolis, Minnesota

An import company in Minneapolis has been put on notice by the FDA for not having FSVP for a number of imported food products.

In an October 19 warning letter, the FDA described an inspection of the Foreign Supplier Verification Program (FSVP) on June 16, 17, and 22, 2021 from Bella Rosa Distribution in Minneapolis, MN.

The FDA inspection found that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The company has not developed, maintained or monitored FSVP for any of the foods it imports, including the following foods:

  1. Watermelon powder for instant drink imported from Insta Foods in India.
  2. Spaghetti imported from Pastificio Attilio Mastromauro Granoro srl in Italy.
  3. Rice imported from Hayat Industries (Pvt) Ltd. in Pakistan.

The full warning letter can be viewed here.

BN Trading Inc.
Chicago Ridge, Illinois

An Illinois import company has received an FDA notice for not having FSVPs for a number of imported food products.

In an October 1 warning letter, the FDA described a June 14-25, 2021 Foreign Supplier Verification Program (FSVP) inspection of BN Trading Inc. in Chicago Ridge, IL.

FDA inspection found that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The company has not developed, maintained or monitored FSVP for any of the foods it imports, including the following foods:

  • Dry mauve molokhia imported from (redacted);
  • Tahina imported from (redacted);
  • Eggplant makdous imported from (redacted),
  • Soup appetizer imported from (redacted); and
  • Roasted and peeled organic chestnuts imported from (redacted).

The full warning letter can be viewed here.

Selected Foods and Beverages Inc.
Houston, TX

A Texas import company has been issued formal notice by the FDA for not having FSVPs for a number of imported food products.

In a September 7 warning letter, the FDA described a May 6-25, 2021 Foreign Supplier Verification Program (FSVP) inspection of Selected Food and Beverage Inc. in Houston, TX.

The FDA inspection found that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The company has not developed, maintained or monitored FSVP for any of the foods it imports, including the following foods:

  • Olive oil imported from (redacted)
  • Imported quartered artichokes in brine (redacted)
  • Tomato sauce imported from (redacted)

The full warning letter can be viewed here.

(To subscribe to Food Safety News for free, Click here.)


Source link

Comments are closed.