China NMPA Inspection - Chongqing Xinwen Medical Equipment Co., Ltd. - January 09, 2018

An unannounced inspection of Chongqing Baihe Medical Device Co., Ltd. was conducted on November 22-23, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection revealed nine deficiencies, comprising four critical and five general issues, indicating significant breakdowns in the company's quality management system.

Key violations included quality management personnel lacking defined responsibilities for supplier and product verification, adverse event monitoring, and recalls. The quality management system itself was unapproved. Critical record-keeping deficiencies were noted, with missing forms for adverse event monitoring and in-stock maintenance, and inadequate retention period guidelines for sales records of certain products. Essential product identifiers, such as batch numbers and registration certificates, were absent from equipment and delivery documentation. Furthermore, quality management personnel were inactive, training records lacked assessment details, and employee health records were outdated. The inspection also identified inadequate business premises and a disorganized warehouse, alongside the absence of a computerized quality management system and proper sales personnel authorizations.

Consequently, the Chongqing Municipal Food and Drug Administration ordered the company to immediately cease operations for rectification. Legal actions for identified violations are to be pursued, followed by re-inspection. Upon successful rectification, the status must be reported to the Medical Device Supervision Department of the State Administration for Market Regulation.