FDA 483 - Datascope Corp. - June 11, 2018

Datascope Corporation in Fairfield, NJ, was inspected and received a Form FDA 483 with 11 observations primarily related to significant deficiencies in their quality system. Key issues include inadequate process validation for MCP tubing kits, insufficient design control procedures, and failures in reporting device corrections, removals, and medical device reports to the FDA in a timely manner. The findings indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.