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

Source: https://www.keypedia.com/records/warning_letter/aju-pharm-co-ltd/2a86c656-cbdb-481f-a14f-a827616ed6c1

> FDA WARNING_LETTER for Aju Pharm Co., Ltd. on January 23, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Aju Pharm Co., Ltd.
- Inspection Date: 2025-01-23
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/raquel-peat/4631fa29-2503-4266-ab3b-4abf36d68a71)

Company: https://www.keypedia.com/companies/aju-pharm-co-ltd/32a3220a-73c8-438b-a8df-c9d68a3f9d36

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