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# Recurring QS Violations at Won Industry
- URL: https://www.fdaweb.com/recurring-qs-violations-at-won-industry/
- Published: 2020-02-04T12:00:00.000Z
- Updated: 2026-09-14T16:01:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146003

A 4/8-4/11/19 FDA inspection at Won Industry Co., Siheung-si, Republic of Korea, found Quality System Regulation violations in the firm’s manufacturing of the Morning Life Compression Limb Therapy System. The inspection was a follow-up to a 2015 inspection and found recurring violations. A just-released 8/29/19 Warning Letter says the specific violations were: 

- failing to adequately establish and maintain procedures for implementing corrective and preventive action;
- failing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failing to adequately establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and regulatory requirements.

The letter also says the firm’s Morning Life system is misbranded because the company failed to develop, maintain, and implement written Medical Device Reporting procedures, including procedures for the timely and effective identification, communication, and evaluation of reportable events, the timely transmission of medical device reports to FDA, or for compliance with the applicable documentation and record-keeping requirements.

The company’s responses to the inspection observations were inadequate, FDA says.

The agency placed the company on a second import alert due to the recurring violations. Won Industry was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion of the corrections.