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AUSTROFOOD S.A.S., an Ecuador-based manufacturer of fruit puree products, violated Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations while producing apple cinnamon fruit puree pouches that contained extremely high concentrations of lead. The contaminated product, intended for infants as young as six months and the general public, resulted in a recall of 39 lots comprising nearly 3 million units distributed between November 2022 and October 2023, following a multistate FDA and CDC investigation that detected elevated lead levels in multiple lots. The FDA inspection from December 4-14, 2023 identified serious violations of 21 CFR Part 117 and the Federal Food, Drug, and Cosmetic Act, rendering the products adulterated due to the presence of added poisonous or deleterious substances injurious to health.