FDA 483 - Precision Diabetes Inc. - March 08, 2024

Precision Diabetes Inc., a specification developer of Class II GlycoMark® IVD kits in Raleigh, NC, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, indicating a broad breakdown in the firm's quality management system. Observations included a lack of established procedures for design control, corrective and preventive action, nonconforming product, supplier management, acceptance activities, and management review, alongside a failure to perform internal quality audits.