HeartWare Inc – FDA Warning Letter, Jan 24, 2014

On January 13-24, 2014, an FDA inspection of HeartWare, Incorporated's Miami Lakes, Florida facility, which manufactures the HeartWare Ventricular Assist Device (HVAD) system, revealed the device to be adulterated. The manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to current good manufacturing practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to validate device design (21 CFR 820.30(g)):** The firm's Design Control System Procedure did not require design validation of device labeling (Patient Manual) for patient/caregiver understanding. The firm's responses were inadequate as they did not detail retrospective validation activities for the HVAD system. 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** * The firm failed to verify or validate the effectiveness of corrective actions for HVAD controller failures (27 complaints, 2 deaths, 4 serious injuries) attributed to ESD. * CAPA procedures were not adequately implemented for premature battery failure issues (238 complaints, MDR events). * Rework of controller inventory with an updated ESD shield design and field actions were not completed after the updated design's release.