FDA WARNING_LETTER - Chamberlain Farms, Inc. - August 31, 2012

An FDA inspection of Chamberlain Farms, Inc. from August 14-31, 2012, and September 19-21, 2012, was prompted by a nationwide Salmonella outbreak (Typhimurium and Newport) linked to the firm's cantaloupes, resulting in 261 illnesses and 3 deaths. Samples from the packinghouse and a distributor yielded outbreak strains of Salmonella Newport, rendering the cantaloupes adulterated under Section 402(a)(1) of the Act. Environmental swabs from the packinghouse also tested positive for Salmonella Newport and Anatum, indicating insanitary conditions under Section 402(a)(4) of the Act. Documented deficiencies included accumulated organic material on conveyors, debris under belts, standing water, bird excrement above food contact surfaces, improper roof drainage, use of non-cleanable materials (carpet, wood) as food contact surfaces, and unprotected wellheads with water samples positive for Coliforms and E. coli. While some immediate corrective actions were taken during the inspection, the firm failed to provide long-term plans. The letter also noted widespread Salmonella contamination in growing fields. The FDA requires a written response within 15 working days detailing specific, long-term corrective actions, prevention plans, and a timetable to avoid further action, such as product seizure or injunction.