Distribucion Y Representaciones Comerciales S.A. – FDA Warning Letter, Nov 15, 2011

The FDA inspected Distribucion Y Representaciones Comerciales S.A.'s juice processing facility in Chile on November 14-15, 2011, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). Consequently, the firm's 100% shelf-stable bottled juice products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the absence of a written hazard analysis and HACCP plan for Apple, Plum, Quince, and Grape juices to control hazards like pathogens, chemicals, and physical contaminants, as required by 21 CFR Parts 120.7(a) and 120.8(a). Additionally, the firm failed to include control measures in its HACCP plan to achieve a 5-log reduction of pertinent microorganisms (21 CFR 120.24(a)) and lacked a Sanitation Standard Operating Procedure (SSOP) addressing eight critical sanitation areas, as mandated by 21 CFR 120.6(a). The FDA requires a written response within thirty working days detailing corrective actions and supporting documentation. Failure to adequately respond may lead to refusal of admission for imported products, including detention without physical examination (DWPE), and assessment of re-inspection fees.