FDA WARNING_LETTER - Bionet Co., Ltd. - April 21, 2011

On April 18-21, 2011, an FDA inspection of Bionet Co., Ltd. in Seoul, South Korea, revealed that their patient monitoring, fetal monitoring, and ECG analysis systems are adulterated. The manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure (BQP-QM-O9) lacks definitions for investigating quality incidents, identifying/implementing corrective actions, verifying/validating effectiveness, identifying documentation changes, disseminating results, and documenting activities. The firm admitted to not following the procedure, lacking a CAPA form, and performing actions outside a formal CAPA system. Three reviewed quality events from their database were not documented per any CAPA procedure. The firm's May 4, 2011, response, including a revised CAPA procedure and new documentation for the three events, was deemed inadequate as a promised retrospective review was not provided.

2. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: The complaint procedure does not define how MDR reportable event evaluations will be documented, and the complaint form lacks a field for this. Four reviewed