FDA WARNING_LETTER - Linkwin Technology Co Ltd - July 02, 2015

On November 5, 2015, the FDA issued a Warning Letter to Linkwin Technology Co. Ltd. following an inspection from June 29 to July 2, 2015, which found their powered heating pads (3-in-1 braces) to be adulterated. The devices were manufactured in non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints, including determining the need for MDR reporting and investigations. The firm's response was inadequate, lacking specific procedural revisions, a timeframe, and retrospective review. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to adequately establish and maintain CAPA procedures, specifically regarding verification of effectiveness and adverse effects on finished devices. The response was inadequate, not indicating a CAPA procedure revision or retrospective review. 3. **Rework Procedures (21 CFR 820.90(b)(2)):** Failure to establish adequate rework procedures, including retesting/reevaluation, adverse effect determination, and DHR documentation. The response was inadequate, lacking specific revisions, a timeframe, and retrospective review. 4. **Design Control