FDA WARNING_LETTER - Asociacion de Pequenos Agricultores Comalapenses de Producto - December 13, 2012

The FDA inspected Asociacion de Pequenos Agricultores Comalapenses de Productos No Tradicionales' produce farm and packing house in San Juan Comalapa, Guatemala, from December 11-13, 2012. The inspection revealed significant objectionable conditions, causing the produce to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)], due to preparation, packing, or holding under insanitary conditions.

The primary violation identified was the presence of three unsealed, dirt sewage pits, ranging from 5 to 32 feet deep, collecting sewage and processing wastewater. These pits are exposed to insects and animals, potentially spreading pathogens. Their location, uphill and 4 to 30 feet directly adjacent to blackberry and pea growing fields, creates a risk of seepage and overflow onto the fields during rain.

The FDA issued an FDA-483, Inspectional Observations, at the inspection's conclusion. Despite a promise to correct, no response or corrections have been received. The firm is required to respond in writing within 15 working days, detailing specific corrective actions, including documentation and photographs. Failure to respond adequately may result in further action, such as refusal of admission of imported produce under Section 801(a) of the Act [21 U.S.C. §