China NMPA Inspection - Hunan Banghua Medical Supplies Co., Ltd. - April 26, 2016

An unannounced on-site inspection, conducted by regulatory authorities, revealed that Hunan Banghua Medical Supplies Co., Ltd. was in a complete state of shutdown. The inspection, which aimed to assess operational compliance, found the company's premises to be sealed off by an order from the Liuyang City People's Court. This significant impediment prevented the inspectors from evaluating active manufacturing processes or quality systems, as the facility was entirely non-operational. The primary issue identified was the company's inability to conduct normal business operations due to this legal action, rather than specific manufacturing deficiencies found during an active production phase. In accordance with the regulatory framework overseen by the Hunan Provincial Food and Drug Administration, stringent protocols must be followed before Hunan Banghua Medical Supplies Co., Ltd. can consider resuming any production activities. The company is mandated to prepare and submit a detailed written report to the Hunan Provincial Food and Drug Administration. This report must comprehensively outline the measures taken to address the circumstances leading to the shutdown and demonstrate full compliance with all applicable regulations. Production is strictly prohibited until the Hunan Provincial Food and Drug Administration has thoroughly reviewed the submitted report and formally verified that all stipulated requirements and regulatory obligations have been met, ensuring a compliant and safe operational environment.