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

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