High Spot Industrial Company, Ltd. – FDA Warning Letter, Apr 15, 2015

On August 25, 2015, the FDA issued a Warning Letter to High Spot Health Technology Co., Ltd. following an inspection from April 13-15, 2015, in Taichung City, Taiwan. The inspection revealed that the firm's mechanical and electric bariatric positioning chairs, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

The letter detailed several violations, including: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for analyzing quality data sources, verifying/validating CAPAs, and identifying outsourced component nonconformances. Four CAPA records lacked effectiveness verification. The firm's response was inadequate, with unclear explanations for outsourced nonconforming components and no retrospective review of past CAPAs. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Procedures did not include requirements for evaluating complaints for MDR reportability. The response was inadequate, as procedures did not describe how regulatory requirements are used or the utilization of the Exception Handling Form. 3. **Failure to establish and maintain nonconforming product disposition procedures (21 CFR