FDA 483 - Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - October 26, 2021

An FDA inspection of Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy, conducted from October 19 to October 26, 2021, resulted in a significant observation documented on an FDA Form 483. The primary issue, identified under the Federal Food, Drug and Cosmetic Act, concerned the production of hazardous drugs without adequate containment, segregation, and personnel cleaning procedures to prevent cross-contamination. Inspectors specifically noted a technician's personal protective equipment (PPE) gown sleeve making direct contact with work surfaces in the hazardous drug compounding room during cleaning operations, both before and after preparing a hazardous non-sterile drug product. Since the same gown was used for multiple tasks throughout the day, this practice presented a substantial risk of transferring hazardous drug residues between different products. Compounding this, the company's "Competency Assessment: Hazardous Drug Hand Hygiene and Garbing" procedure lacked a requirement for changing gowns or sleeves when compounding distinct hazardous drug products. These findings underscore the firm's need to implement comprehensive corrective actions, including updating procedures and refining practices, to ensure effective containment and prevent cross-contamination, safeguarding product quality and patient safety.