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Santa Cruz Produce, Inc. failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by the Federal Food, Drug and Cosmetic Act for the fresh produce it imported into the United States. During an FDA inspection in November 2022, investigators found that the company had not established an FSVP for any of its imported foods, including fresh mangoes, and the company failed to respond to the inspection observations within the required 15-business-day timeframe. This violation of 21 CFR Part 1, Subpart L represents a significant failure to implement the risk-based verification activities needed to ensure imported foods meet applicable U.S. food safety standards.