FDA 483 - OHIRA CO., LTD - February 27, 2020

An FDA inspection of OHIRA CO., LTD in Minamiuonuma-shi, Japan, revealed significant deficiencies in their device history record (DHR) procedures. The firm failed to adequately establish DHR procedures to ensure devices were manufactured according to the device master record (DMR). Additionally, reviewed DHRs lacked essential information such as primary identification labels, labeling, and unique device identifiers.