FDA WARNING_LETTER - Aju Pharm Co., Ltd. - January 23, 2025

On May 21, 2025, the FDA issued a Warning Letter to Aju Pharm Co., Ltd. following an inspection from January 20-23, 2025, in Seongnam-Si, Gyeonggi, South Korea. The inspection found that the firm's Class II Fixone Hybrid Knotless Anchor and Fixone Biocomposite Anchor devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and failure to establish and maintain medical device report procedures (21 CFR § 803.17).

Specific violations included: 1. **Failure to adequately establish procedures for validating device design (21 CFR 820.30(g))**: The firm distributed devices since 2023 without performing design validation activities, and their corrective action plan was deemed inadequate for lacking a systemic approach and patient risk assessment. 2. **Failure to adequately establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm did not initiate CAPAs for identified suture anchor issues from 2022-2023 complaint data. Their response was inadequate for not including a systemic approach, retrospective review, or investigation into the cause of nonconformities. 3. **Failure to