# FDA WARNING_LETTER - Merits Health Products Co., Ltd - July 14, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/merits-health-products-co-ltd/6bf45282-6b06-4bb3-be68-53cd95556e8e

> FDA WARNING_LETTER for Merits Health Products Co., Ltd on July 14, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Merits Health Products Co., Ltd
- Inspection Date: 2011-07-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 11-14, 2011, an FDA inspection of Merits Health Products Co., Ltd. in Taichung, Taiwan, revealed that their powered wheelchairs, stair chair lifts, and electric scooters were adulterated under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to ensure processes are validated with approved documentation. The firm lacked approval for validation protocols, and provided inadequate corrective actions.
2.  **CAPA Procedures (21 CFR 820.100(a)):** Inadequate procedures for corrective and preventive action. Rework activities were not consistently captured in the CAPA system, and the firm's 5% threshold for CAPA initiation lacked documented procedures.
3.  **Finished Device Acceptance (21 CFR 820.80(d)):** Failure to ensure finished devices meet acceptance criteria. Several P326A powered wheelchairs were approved with out-of-specification speed results without justification or correction.
4.  **Rework Procedures (21 CFR 820.90(b)(2)):** Inadequate rework procedures, including

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/merits-health-products-co-ltd/96e63311-ecea-4788-9b03-212f93612eb5

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