Nihon Kohden America LLC – FDA 483, Apr 30, 2019

Nihon Kohden America Inc., a medical device importer and manufacturer in Irvine, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to submit timely and complete Medical Device Reports (MDRs), inadequately documented corrective and preventive actions (CAPAs), and did not properly investigate customer complaints. Additionally, training procedures were found to be insufficient, and a critical quality agreement with a product manufacturer had expired.