# FDA WARNING_LETTER - Won Industry Co. LTD - April 11, 2019

Source: https://www.keypedia.com/records/warning_letter/won-industry-co-ltd/c6a3e437-b258-4ee3-af98-4c516e9f2e6e

> FDA WARNING_LETTER for Won Industry Co. LTD on April 11, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Won Industry Co. LTD
- Inspection Date: 2019-04-11
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 29, 2019, the FDA issued a Warning Letter to a firm in Siheung-si, Republic of Korea, following an inspection from April 8-11, 2019, which was a follow-up to a 2015 inspection. The firm manufactures the Morning Life Compression Limb Therapy System, classified as a medical device. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations, many recurring from the 2015 inspection, include:
1.  **Failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a))**: The firm did not investigate root causes of deficiencies identified in the previous FDA-483, nor verify/validate CAPAs to ensure effectiveness. The firm's response was inadequate as it lacked evidence of comprehensive investigation and retrospective analysis.
2.  **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: The procedure did not require evaluation for Medical Device Reporting (MDR) under 21 CFR Part 803 or recording of unique device identifiers/complainant contact information. The firm

## Related Officers

- [Director](https://www.keypedia.com/people/carlos-l-pena/4a53ea5f-ee50-49a8-b0e3-daa220e2b98e)
- [Min Seo](https://www.keypedia.com/people/min-seo/78a3af4f-801d-4f11-8f16-0523b9e04d43)

Company: https://www.keypedia.com/companies/won-industry-co-ltd/08623220-d997-43b9-8456-06092bc99b2b

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