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Aju Pharm Co., Ltd., a South Korean manufacturer of Class II orthopedic anchors (Fixone Hybrid Knotless Anchor and Fixone Biocomposite Anchor), was found to have adulterated devices due to non-compliance with FDA quality system regulations under 21 CFR Part 820. During a January 2025 inspection, the FDA identified critical failures including inadequate design validation procedures—notably, the company had distributed the Fixone Hybrid Knotless Anchor in the U.S. since 2023 without performing required design validation activities—and failure to establish and maintain proper medical device reporting procedures as required by 21 CFR § 803.17. The company's response to initial inspection observations in February 2025 did not adequately address the documented violations.