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

Source: https://www.keypedia.com/records/warning_letter/linkwin-technology-co-ltd/20faa69a-3fe6-41ff-8ae9-430813a5b3bc

> FDA WARNING_LETTER for Linkwin Technology Co Ltd on July 02, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Linkwin Technology Co Ltd
- Inspection Date: 2015-07-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Allen Kuo](https://www.keypedia.com/people/allen-kuo/de1d08f5-0732-47a6-a871-0e193f731555)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.keypedia.com/companies/linkwin-technology-co-ltd/6138927c-b3b4-4568-a6a3-0b028be9a0d3

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