FDA WARNING_LETTER - GaleMed Xiamen Co., Ltd. - December 12, 2013

On December 9-12, 2013, an FDA inspection of GaleMed Corporation in Xiamen, China, revealed violations concerning manual emergency ventilators, manual resuscitators, positive end expiratory pressure breathing attachments, and continuous facility use ventilators. The firm's devices were deemed misbranded under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Significant violations included: 1. **Failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17):** The firm lacked a written MDR procedure. The subsequently developed procedure (dated 12-25-2013) was inadequate, omitting definitions for "become aware," "reasonably known," and "reasonably suggests," which could lead to incorrect reportability decisions. It also lacked instructions for obtaining and completing FDA 3500A forms for timely report transmission. 2. **Quality System Regulation (21 CFR Part 820) Nonconformances:** * **Failure to establish and maintain CAPA procedures with statistical methodology (21 CFR 820.100(a)(1)):** The CAPA procedure did not require statistical analysis to detect recurring quality problems, and no CAPAs were initiated based on data analysis. (Response