DF Global, Inc. – FDA Warning Letter, Mar 30, 2022

On August 1, 2022, the FDA issued a Warning Letter to DF Global, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on March 30, 2022, and a previous inspection on January 15, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, for imported foods.

The FDA found DF Global, Inc. non-compliant for imported Honey Hallabong Tea, Ginger Lemon Tea, and Tea from a specific foreign supplier. Key violations include:

1. **Inadequate Hazard Analysis (21 CFR 1.504):** The company failed to identify undeclared allergens (walnuts, almonds) and natural toxins (mycotoxins) as hazards requiring control in their "Tea (powder type)" hazard analysis. They also did not evaluate allergen controls for Honey Hallabong Tea and Ginger Lemon Tea, or mycotoxins for Tea, despite product labels indicating allergens.

2. **Insufficient Foreign Supplier Verification Activities (21 CFR 1.506(e)):** The third-party onsite audit report for the foreign supplier, dated April 22-23, 2021, noted multiple deficiencies (e.g., lack of cleaning standards, insufficient instrument calibration, inadequate hazard identification). However, the company did