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. The FDA frequently redacts parts of warning letters posted for public view.
California Terra Garden Inc.
Commerce, 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 Nov. 10 warning letter, the FDA described a May 11 through June 8, 2021, Foreign Supplier Verification Program (FSVP) inspection of California Terra Garden Inc. in Commerce, 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 firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
- Specifically, the firm’s king oyster mushrooms imported from (redacted), enoki mushrooms imported from (redacted), and fresh seafood mushrooms imported from (redacted), are raw agricultural commodities, but the firm’s supplier evaluation and approval did not consider the suppliers’ compliance with the requirements of the Produce Safety Rule.
- The firm’s response to the FDA 483a dated June 22, 2021, states that they suspended and canceled orders from their suppliers of enoki and seafood mushrooms and that they intend to “[r]eview the supplier approval process, impose tighter control, and perform more testing.” The FDA is unable to review the adequacy of their response because they did not describe how they would determine whether their suppliers are producing the foods in accordance with the Produce Safety Rule. The firm also did not provide any information regarding their review of processes and procedures related to produce safety for their suppliers of other imported covered produce, such as king oyster mushrooms.
- The firm’s supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods they import have been significantly minimized or prevented. FDA has determined that the biological hazards in covered produce require a control, and compliance with the requirements in the Produce Safety Rule significantly minimizes or prevents the biological hazards. However, their verification activities did not include verifying their suppliers’ compliance with the Produce Safety Rule or documenting processes or procedures that provide at least the same level of public health protection as required by the Produce Safety Rule.
The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
The full warning letter can be viewed here.
Bella Rosa Distribution Inc.
Minneapolis, MN
An import company in Minneapolis is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 19 warning letter, the FDA described a June 16, 17 and 22, 2021, Foreign Supplier Verification Program (FSVP) inspection of Bella Rosa Distribution in Minneapolis, MN.
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 firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
- Instant Drink Powder Watermelon imported from Insta Foods in India.
- Spaghetti imported from Pastificio Attilio Mastromauro Granoro srl in Italy.
- Rice imported from Hayat Industries (Pvt) Ltd. in Pakistan.
The full warning letter can be viewed here.
BN Trading Inc.
Chicago Ridge, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 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.
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 firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
- Dry mallow molokhia imported from (redacted);
- Tahina imported from (redacted);
- Eggplant makdous imported from (redacted),
- Soup starter imported from (redacted); and
- Organic chestnuts roasted and peeled imported from (redacted).
The full warning letter can be viewed here.
Selected Food & Beverage 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 a Sept. 7 warning letter, the FDA described a May 6 and 25, 2021, Foreign Supplier Verification Program (FSVP) inspection of Selected Food and Beverage Inc. in Houston, 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 firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
- Olive Oil imported from (redacted)
- Artichokes Quartered in Brine imported (redacted)
- Tomato Sauce imported from (redacted)
The full warning letter can be viewed here.
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