Bionetek Corporation – FDA Warning Letter, Jan 27, 2011

On April 18, 2011, the FDA issued a Warning Letter to Bionetek Corporation following an inspection from January 5-27, 2011, which found the CARDx Early Cardiac Diagnostic (ECD) system, an investigational device, to be adulterated. The device's pre-production design controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain procedures for device design control (21 CFR 820.30(a)), specifically lacking procedures for design input, output, review, verification, validation, transfer, and changes, and no documented design verification. 2. Failure to establish and maintain design and development plans (21 CFR 820.30(b)) for the CARDx ECD device. 3. Failure to establish and maintain a Design History File (DHF) (21 CFR 820.30(j)) for the CARDx ECD device.

Bionetek's February 10, 2011, response, which provided SOP 1050 Rev 1, Design Control, was deemed inadequate as it lacked a specific implementation plan, timeline, or evidence of implemented corrections and corrective actions.

The FDA requires prompt corrective action within fifteen business days, including a written response detailing specific steps taken