FDA 483 - Jalisco Fresh Produce, Inc. - February 24, 2025

During an inspection conducted on February 24, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to JALISCO FRESH PRODUCE. The primary observation highlighted a critical deficiency in the company's compliance with federal food safety regulations. Specifically, JALISCO FRESH PRODUCE failed to develop a Foreign Supplier Verification Program (FSVP) for all imported foods. This issue was identified as a repeat observation, having also been cited in a previous inspection between October 7, 2022, and October 14, 2022, indicating a persistent non-compliance. The company explicitly confirmed the absence of an FSVP for a range of imported products from specific foreign suppliers during the period of February 1, 2024, to January 31, 2025. Examples of these imported items include Jalapeno Peppers and White Onions. The FSVP regulation, mandated under Section 805 of the Federal Food, Drug, and Cosmetic Act, requires importers to establish programs to ensure that foreign suppliers produce food in a manner that provides the same level of public health protection as required of domestic producers. To address this observation, JALISCO FRESH PRODUCE must develop and implement a comprehensive FSVP for all relevant imported foods to ensure compliance and consumer safety.