FDA EIR - Citrus And Allied Essences Ltd. - June 23, 2021

An FDA inspection of Citrus And Allied Essences Ltd., located in Belcamp, MD, was conducted on June 23, 2021. This inspection, carried out under a contract between the FDA and the Maryland Department of Health, focused on current good manufacturing practices and limited preventive controls for their food-grade flavor and fragrance ingredients, which include essential oils and aroma chemicals. The scope covered processes pertaining to manufacturing, labeling, storage, and distribution, alongside sanitation, pest control, temperature monitoring, cross-contact prevention, employee training, consumer complaints, and product recalls.

Labels for products like Oil Lemon Terpenes EX 5-Fold and Oil Orange Valencia 5-Fold were reviewed for compliance with general food labeling requirements and the Food Allergen Consumer Protection Act (FALCPA). Crucially, the inspection concluded with no objectionable conditions observed, and consequently, a Form FDA 483, which details inspectional observations, was not issued. The final classification for this inspection was "No Action Indicated" (NAI), signifying that no regulatory violations were found and therefore no specific actions are required from the company based on this inspection. This outcome indicates the firm's adherence to regulatory standards.