# FDA WARNING_LETTER - Ace Medical Corp., Ltd. - January 24, 2013

Source: https://www.keypedia.com/records/warning_letter/ace-medical-corp-ltd/45e23fea-476c-4b65-916a-4d89b3ad2272

> FDA WARNING_LETTER for Ace Medical Corp., Ltd. on January 24, 2013. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Ace Medical Corp., Ltd.
- Inspection Date: 2013-01-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On May 1, 2013, the FDA issued a Warning Letter to Ace Medical Corp., Ltd. following a January 21-24, 2013 inspection in Goyang-Si, Gyeonggi-Do, South Korea. The inspection revealed that the firm's Infusion Pumps and Elastomeric Infusion Pumps were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) requirements.

Key violations included:
1.  **Design Validation (21 CFR 820.30(g)):** Failure to establish and maintain procedures for validating device design, including testing production units under actual or simulated use conditions. The firm's Design Control Procedure was inadequate, and the Design History File for the AutoSelector Elastomeric Infusion Pump lacked evidence of pre-shipment design validation. The firm's response was insufficient, lacking a protocol for new validation, employee training evidence, and a review of other products/design projects.
2.  **Process Validation (21 CFR 820.75(a)):** Inadequate validation of processes where results cannot be fully verified by subsequent inspection and test. Specifically, the validation for a sealing process lacked evidence of statistically valid sample sizes, challenged process parameters (worst-case testing), and acceptance criteria. The firm

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Andrew Lamborne](https://www.keypedia.com/people/andrew-lamborne/7cb669b7-2d6a-431c-b278-c17ded78b68e)
- [Sang Won Kim](https://www.keypedia.com/people/sang-won-kim/920f9c11-f254-45a3-9f60-31682b1e84b0)

Company: https://www.keypedia.com/companies/ace-medical-corp-ltd/46bfcadb-96fa-40d9-a033-b884c0e2f093

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