DN Imports, Inc – FDA Warning Letter, Jun 11, 2020

On September 4, 2020, the FDA issued a Warning Letter to DN Imports, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection from May 15 to June 11, 2020, and a previous inspection on April 20, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found DN Imports, Inc. non-compliant for not having FSVPs for mushroom soup powder and seasoning sauce with garlic and chili imported from one foreign supplier, and roasted corn from another. This violates section 805 of the FD&C Act. The firm received Form FDA 483a observations after both inspections.

While DN Imports, Inc. responded via email on June 21 and July 29, 2020, stating plans to implement FSVPs, the FDA could not evaluate the responses due to a lack of supporting documentation for the specific products cited. A submitted "Food Safety Verification Form" for "Maggi Soy Sauce Seasoning Concentrate" was also deemed non-compliant, lacking hazard analysis (21 CFR 1.504), foreign supplier performance evaluation (21 CFR 1.505), and verification activities (21 CFR 1.506).

The letter specifies the violation of not developing