FDA WARNING_LETTER - GRI Medical & Electronic Technology Co., Ltd. - December 20, 2012

On December 17-20, 2012, an FDA inspection of GRI Medical & Electronic Technology Co., Ltd. in Jiaxing, Zhejiang, China, revealed that their sterile and non-sterile medical devices, including surgical gowns, drapes, and various other medical products, were adulterated. This means their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The inspection identified seven key violations: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** The firm's CAPA procedure was incomplete, lacking criteria to trigger CAPAs based on data analysis of complaints, process rejects, or supplier performance. The firm's response was inadequate as it lacked evidence of a systemic corrective action plan and retrospective data analysis of complaints. 2. **Failure to control nonconforming product (21 CFR 820.90(a)):** Nonconforming products were found without required identification documentation. The firm's response was inadequate, lacking evidence of a systemic corrective action plan addressing all products. 3. **Failure to control production processes (21 CFR 820.70(a)):** In-process inspections were not conducted as required, and equipment parameters were not maintained according to specifications. The firm's response was inadequate, lacking evidence of a