FDA EIR - Concentrated Aloe Inc. - July 24, 2019

An FDA surveillance inspection of Concentrated Aloe Inc., an acidified food manufacturer and producer of cosmetic oils and sprays located in Ormond Beach, FL, was conducted from July 22-24, 2019. The inspection followed regulatory guidance for acidified foods and cosmetics. Key deficiencies included inadequate pest screening with an open processing room door and structural gaps, improperly labeled cleaning compounds, insufficient working space, and a lack of hot water for sanitation. The facility also showed poor maintenance, with apparent droppings on floors and product storage areas. Additionally, clean manufacturing equipment was found drying on the floor, and the company lacked a required Food Safety Plan. A significant finding was the presence of unauthorized health claims on product labels (e.g., Moringa, Nangai, Tamanu oils) and the www.kavakingproduct.com website, which could classify these products as unapproved new drugs. Company management committed to removing all health claims, setting up tables for proper equipment drying, and developing a comprehensive Food Safety Plan. They were also reminded of their responsibility to ensure ingredient safety and adherence to FDA regulations for future products like dietary supplements or sunscreen.