FDA Letter Dec 16

FDA Letter Dec 16

Mike Stephens
Mike Stephens
News Reporter
For California Ag Today, I’m Mike Stephens

Companies in 4 states warned about 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 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. of Commerce, An import company 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, enoki mushrooms and fresh seafood mushrooms, 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.

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