FDA 483 - Lyden Spice Corporation - June 28, 2021

During an FDA inspection from June 8-28, 2021, Lyden Spice Corporation, an ambient storage warehouse in Miami, FL, received a Form FDA 483 detailing significant food safety and sanitation deficiencies. The most critical observation was the absence of a written food safety plan, including a hazard analysis and preventive controls for ready-to-eat spices, a repeat violation. Inspectors observed widespread and severe rodent activity throughout the facility, with rodent excreta, gnaw marks, nesting materials, and urine stains on packaging for numerous spices like cinnamon, chili pepper, coriander, garlic, and MSG. Several pallets of spices were directly contaminated. Additionally, the company failed to conduct operations under sanitary conditions, evidenced by open doors lacking pest protection, cluttered storage hindering cleaning, damaged product packaging, and unsanitary exterior grounds. Improper pest control was noted, with exposed rodenticide baits and unapproved pesticides found near food products. The regulatory framework for these observations falls under the Federal Food, Drug, and Cosmetic Act, particularly concerning food held under insanitary conditions. Lyden Spice Corporation is required to implement robust corrective actions, including developing a food safety plan, eradicating pests, improving facility design and sanitation, and ensuring employee qualification to prevent food contamination and ensure regulatory compliance.