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Talk to a SpecialistTalk to a SpecialistPurcell International failed to comply with the Foreign Supplier Verification Program (FSVP) requirements when importing apple cinnamon fruit puree and cinnamon apple sauce from its Ecuadorian supplier Austrofood S.A.S. The inspection was triggered by a Class 1 recall initiated in October 2023 after the products were found to contain dangerously elevated lead levels, with samples intended for infants as young as six months. The company's imported products were subsequently placed on Import Alert #99-42 for heavy metal contamination, indicating systemic failures in the supplier verification and risk-based oversight activities required under section 805 of the Federal Food, Drug, and Cosmetic Act.