483
OHIRA CO., LTDFDA 483 - OHIRA CO., LTD - February 27, 2020
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · ef8f7bfc-9f2c-40f5-8020-bf25d334cf64