FDA 483 - Unknown Company - July 03, 2017

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from June 26 to July 3, 2017, Triad Isotopes Inc., a producer of sterile drug products located in Kansas City, MO, received a Form FDA 483 citing significant observations regarding its manufacturing practices. The primary concern highlighted was the production of sterile drugs under insanitary conditions. Specifically, FDA investigators observed several critical deficiencies within the firm's controlled environments. These included the absence of a sporicidal agent in the ISO 5 classification areas designated for sterile operations, which is crucial for preventing microbial contamination. Furthermore, the company was found to be using non-sterile disinfectants within these critical ISO 5 zones, undermining their sterility controls. Additional observations noted a lack of contact sampling performed on permanent equipment within the ISO 5 Laminar Airflow (LAF) hood. This omission meant the firm could not adequately demonstrate the effectiveness of its sanitization procedures for the dose calibrator and peripheral equipment. Lastly, Triad Isotopes Inc. failed to measure the pressure differential between the ISO 5 sterile operations hood and the surrounding environment, a key parameter for maintaining environmental control and preventing ingress of contamination. These observations indicate a need for immediate corrective action to ensure the safety and quality of the sterile drug products manufactured by Triad Isotopes Inc. The company is expected to develop and implement robust responses to address these inspectional findings and uphold regulatory standards.