New India Bazar, Inc. – FDA Warning Letter, Dec 21, 2023

On April 1, 2024, the FDA issued a Warning Letter to New India Bazar, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from November to December 2023. The inspection, prompted by a recall of MAGGI Noodles due to undeclared allergens (peanuts), found significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for imported foods (21 CFR 1.502(a)). 2. Inadequate foreign supplier approval process, relying solely on FDA's Data Dashboard and failing to consider the actual manufacturers for certain products (21 CFR 1.505(a)). 3. Failure to conduct a written hazard analysis for imported foods, specifically omitting allergens as a chemical hazard for MAGGI Noodles, Gujarati Chavana, Gajjak Moongfali Snack, and Chat Papri (21 CFR 1.504). 4. Insufficient foreign supplier verification activities, again relying solely on FDA's Data Dashboard and not adequately considering the foreign suppliers of the foods (21 CFR 1.506(e)).

New India Bazar's January 15, 2024, response was deemed inadequate due to a lack of