Won Industry Co. LTD – FDA Warning Letter, Apr 11, 2019

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