FDA 483 - Heartland I.V. Care - July 14, 2017

An FDA inspection conducted at Heartland I.V. Care in Saint Paul, MN, from July 10-14, 2017, identified a significant observation regarding the facility's cleaning procedures for sterile drug production. The inspection, overseen by FDA representatives Anthony J. Ladner and James K. Ireland, focused on the firm's operations as a producer of sterile drugs, indicating compliance with Current Good Manufacturing Practices is expected. The primary issue noted was the absence of sporicidal agents in the facility's cleanrooms and ISO 5 areas. Specifically, during an observation of compounding on July 10, 2017, inspectors found that Heartland I.V. Care did not utilize a sporicidal agent when cleaning the critical ISO 5 area. Instead, the firm used other agents without sporicidal properties. This deficiency is critical for maintaining a sterile environment, as spores can be resistant to common disinfectants and pose a contamination risk in sterile drug manufacturing. As per the FDA 483 process, Heartland I.V. Care is required to address this observation by either discussing objections or implementing and documenting corrective actions to ensure proper sporicidal cleaning procedures are established and followed in all relevant clean areas to prevent microbial contamination and ensure product quality and safety.