FDA 483 - Duran and Sons, LLC - November 22, 2010

An FDA inspection conducted at Duran and Sons, L L C, a food manufacturer, from November 15-22, 2010, revealed significant deviations from regulatory standards. The primary concerns revolved around widespread pest contamination, inadequate facility maintenance, and poor sanitation practices. Inspectors observed live animals (cats, birds) and extensive evidence of pests including rodents (nests, droppings, gnaw marks, urine) and insects (cockroaches, worms, moths) throughout the finished product warehouse and processing areas, often in direct proximity to or on stored food products like chile pods and ground pepper. The facility's buildings were not maintained to prevent food adulteration, with numerous gaps in walls and doors allowing pest entry. Furthermore, improper storage of equipment, waste, and overgrown vegetation created pest harborage areas both inside and outside the plant. Other critical issues included condensate dripping onto exposed food and packaging, equipment (including a grinder with a chipped blade) not being properly maintained or constructed for food safety, and empty product containers stored directly on the floor. Employee practices were also cited, with observations of inadequate handwashing, eating in food processing areas, and unsanitary restroom conditions. Uncovered lighting fixtures above exposed food posed an additional contamination risk. Duran and Sons, L L C is required to implement thorough corrective actions to address these serious violations of food safety regulations, ensuring effective pest control, structural repairs, improved sanitation, proper equipment maintenance, and comprehensive employee training to prevent food adulteration.