FDA 483 - Cancer Diagnostics Inc. - August 14, 2019

An FDA inspection of Carver Diagnostics Inc. in Durham, NC, a medical device specification developer and repacker/relabeler, revealed six significant deficiencies in its quality system. The firm failed to establish or adequately implement procedures for critical areas such as design control, purchasing, medical device reporting, statistical techniques, quality audits, and management review, indicating a broad lack of compliance with regulatory requirements.