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.

Kim Nhung Marketplace Inc.
Seattle, WA

An import company in Washington state 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 May 5- 21, 2021, Foreign Supplier Verification Program (FSVP) inspection of records submitted by Kim Nhung Marketplace Inc. in Seattle.

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. 

Specifically, the firm did not develop an FSVP for any of the foods they import, including the following foods:

  •  Frozen Taro imported from (redacted).
  • Frozen Steam Sweet Corn (with Husk) imported from (redacted).
  • Frozen Tapioca Noodle imported from (redacted).
  • (Redacted) Rice (redacted) imported from (redacted).

The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.

More specifically, FSVP requires that importers verify that their suppliers are producing food using processes and procedures that offer the same level of public health protection as the preventive controls requirements in the preventive controls and current good manufacturing practices rules for human food and animal food and produce safety U.S. rules in the Food Safety Modernization Act of 2011, and that the food is not adulterated and is properly labeled with respect to allergens.

The full warning letter can be viewed here.

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