FDA 483 - FUJIFILM Wako Chemicals U.S.A. Corporation - May 10, 2024

FUJIFILM Wako Chemicals U.S.A. Corporation and FUJIFILM Healthcare Americas Corporation, an IVD manufacturer in Richmond, VA, received an FDA Form 483 following an inspection from May 6-10, 2024. The document highlighted several significant observations concerning the firm's quality management system, indicating potential non-compliance with regulations governing medical device manufacturing.Key issues included deficiencies in production process control, where environmental monitoring and airborne particle sampling procedures were not followed according to established SOPs during the filling process of a Pyrostar 2.0 Multi product. Equipment calibration and maintenance were also cited, with several lyophilizers and centrifuges found past their scheduled calibration dates. Critically, a capping/labeling machine had long-standing broken components, leading to unverified manual operational deviations and a lack of documented corrective actions. Furthermore, temperature load studies and HEPA filter assessments for specific cleanroom equipment were not evidenced. Finally, the firm's device history record procedures were inadequate, as operators were observed not contemporaneously documenting in-process test results, instead relying on unvalidated interim "scratch paper" for later data transfer. These observations require FUJIFILM to submit a comprehensive response detailing corrective and preventive actions to address the identified issues and ensure adherence to regulatory standards.