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

Source: https://www.keypedia.com/records/warning_letter/heartway-medical-products-co-ltd/f5b5d65f-385d-4ca3-a022-44d97dc557e7

> FDA WARNING_LETTER for Heartway Medical Products Co., Ltd. on October 27, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Heartway Medical Products Co., Ltd.
- Inspection Date: 2011-10-27
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.
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## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/heartway-medical-products-co-ltd/7e99e79d-f1e3-4b9a-be20-20c454ff768f

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7