Conservas y Congelados YAESTA, S.A. – FDA Warning Letter, Oct 29, 2010

On February 17, 2011, the FDA issued a Warning Letter to Conservas y Congelados YAESTA, S.A. following an inspection from October 25-29, 2010. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) for their 100% juice pulp products (e.g., mamey, mango, nance).

Key violations include: 1. Failure to perform a 5-log reduction for Salmonella in frozen fruit pulp, as required by 21 CFR 120.24(a), (b), and (c). 2. The HACCP plan for frozen mamey pulp did not list pasteurization as a critical control point for pathogens (21 CFR 120.8(b)(2)). 3. Absence of HACCP plans for nance pulp and mango pulp exported to the USA to control pathogen hazards (21 CFR 120.8(a)). 4. Failure to maintain sanitation control records for the proper labeling, storage, and use of toxic compounds (21 CFR 120.6(c)).

These deficiencies render the frozen fruit pulp products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The