FDA WARNING_LETTER - Green Food Ingredients, LLC - June 29, 2021

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Green Food Ingredients, LLC from June 23-29, 2021, following a previous inspection in 2020. The inspection revealed significant violations of section 805 of the Federal Food, Drug and Cosmetic Act and the implementing FSVP regulation (21 CFR part 1 subpart L) for imported food products, including Roasted Garlic Powder. The firm failed to respond to the Form FDA 483a issued at the conclusion of the inspection.

Key violations identified include the failure to perform foreign supplier verification activities as required by 21 CFR 1.506, specifically not establishing written procedures or documenting the determination of appropriate activities. The firm also did not adequately conduct a hazard analysis for imported foods as required by 21 CFR 1.504(a), lacking documentation of review and assessment by a qualified individual. Furthermore, the company failed to provide English translations of records, such as the hazard analysis and HACCP plan, upon FDA request, violating 21 CFR 1.510(b)(1).

Green Food Ingredients, LLC is required to respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation. Failure to adequately address these violations may result in further regulatory action, including refusal of admission for imported food products, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.