FDA WARNING_LETTER - AUSTROFOOD S.A.S. - December 14, 2023

The FDA issued a Warning Letter to a facility in Ecuador following a December 2023 inspection, prompted by a multistate investigation into elevated lead levels in apple cinnamon fruit puree pouches. The investigation, initiated in October 2023, linked the products to acute lead toxicity in children. Laboratory analysis by FDA and state partners confirmed extremely high lead concentrations in WanaBana Apple Cinnamon Fruit Puree and Weis Cinnamon Apple Sauce pouches, with the cinnamon ingredient identified as the source, including lead chromate indicative of economic adulteration.

The products were deemed adulterated under 21 U.S.C. § 342(a)(1) for containing a poisonous substance, violating 21 U.S.C. § 331(a) by introducing adulterated food into interstate commerce. The facility violated 21 CFR Part 117 (CGMP & PC rule) by failing to adequately conduct a hazard analysis for lead in cinnamon, a known hazard, especially for young children. Despite having a supply-chain program, the firm did not implement required annual onsite audits for its cinnamon supplier, Negasmart.

The FDA acknowledged the October 2023 recall of 39 lots by WanaBana USA LLC and the firm's revised hazard analyses and supply-chain program, which now identify heavy metals in cinnamon as a hazard requiring preventive controls. However, the FDA noted concerns regarding the adequacy of sampling, analytical