FDA 483 - Fidelitone Order Fulfillment LLC - October 26, 2023

An FDA inspection conducted from October 24-26, 2023, at Fidelitone Order Fulfillment LLC, a repacker/relabeler in Lebanon, TN, revealed significant deficiencies in its quality control systems, leading to the issuance of an FDA Form 483. The primary observation was the absence of an effective quality control unit. Specifically, the firm lacked critical standard operating procedures (SOPs) and practices essential for regulatory compliance. These included the absence of procedures for managing changes (e.g., during a warehouse management system upgrade), controlling label creation and issuance for products like acne gel and shampoo/conditioner, and implementing a robust Corrective and Preventive Action (CAPA) system for addressing issues like equipment failures. Furthermore, Fidelitone had not established SOPs or performed qualification and validation for its processes and equipment, such as new ink jet printing machines used for product labeling. The inspection also noted a lack of documented responsibilities between Fidelitone and its clients regarding repackaging and labeling, and the absence of qualification or quality agreements with packaging material suppliers. These observations indicate a need for Fidelitone Order Fulfillment LLC to establish and implement comprehensive quality management systems to ensure compliance with relevant Good Manufacturing Practices for drug products, thereby rectifying the identified deficiencies in its operations.