FDA EIR - Shirakawa Olympus Co., Ltd. - May 21, 2015

Shirakawa Olympus Co., Ltd., a medical device manufacturer located in Nishishirakawa-Gun, Japan, underwent a Level 2 Quality System Inspection Technique (QSIT) inspection by the FDA from May 18 to May 21, 2015. This routine inspection, conducted under the FDA's medical device workplan, evaluated all four major quality subsystems, focusing on products like the endocapsule, a Class II device for small intestine imaging. A primary objective was to verify the implementation of voluntary corrective actions in response to deficiencies noted in a prior March 2012 inspection, which had cited issues with design validation. The current inspection confirmed that these previous observations had been successfully addressed. Significantly, no FDA-483 form was issued at the conclusion of the 2015 inspection, indicating that no new significant violations or non-compliance issues were identified. Consequently, no new immediate regulatory actions were required from Shirakawa Olympus Co., Ltd. as a direct outcome of this inspection, reflecting a satisfactory state of their quality management systems for medical device manufacturing.