FDA WARNING_LETTER - Heartway Medical Products Co., Ltd. - October 27, 2011

On October 24-27, 2011, an FDA inspection of Heartway Medical Products Co., Ltd. in Taichung, Taiwan, identified that their S11 Zen Power Mobility Scooter and other motorized vehicles are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: Eleven CAPAs lacked documented implementation evidence. The firm's response was inadequate, providing only a template without addressing the observation or demonstrating implementation. 2. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: Eleven complaints lacked Medical Device Report (MDR) evaluations. The firm's response was inadequate, providing a proposed record but not the full procedure or addressing all complaint file requirements. 3. **Failure to establish and maintain adequate design validation procedures (21 CFR 820.30(g))**: Design validation for the Zen Power Mobility Scooter lacked identification of devices, test conditions (actual/simulated use), and methodology. The firm's response was inadequate, providing a general template without specific details or evidence of systemic corrective action. 4.