The State Food and Drug Administration issued a plan and Wuhan Kerui was suspended from production and rectification.

On May 14, the State Drug Administration issued a circular on the suspension of production and rectification of Wuhan Keruidi Medical Products Co., Ltd. on May 14.

There are two serious defects and eight general defects in the production quality management system. drug The supervision authority instructed Hubei Food and Drug Administration to order it according to law enterprise Immediately stop production and rectification, and recall related products.

The company’s flight inspection report showed that, among them, two serious flaws were:

1, On-site inspection of the 10L PE barrels in direct contact with liquid B from January to April of 2018 purchase The records show that the company purchased 17122001 batches of 5000 10L PE barrels, 18011101 batches of 10L PE barrels, to view the two batches of picking records and inventory, showing that all runs out of stock, no inventory, but the company 2018-1 The April B liquid production record shows a total of 24 batches of production, using about 7,500 10LPE barrels in the 17122001 batch and about 6,795 using the 10,011 litre PE barrels in the 18011101 batch, which is inconsistent with the picking record and inventory situation, and cannot be traced back. It does not comply with the “Specifications”. Each batch (table) product should have a production record and meet the traceability requirements.

2. The company conducted a management review on October 27, 2017. The review concluded that 'employee's understanding of the company's quality documents is not enough to enhance training and learning'. The preventive measures are 'enhanced system learning', but the company cannot provide improvement measures on the site. And relevant training records, inconsistent with the "Code", enterprises should regularly carry out management review, evaluate and review the quality management system to ensure its continued suitability, adequacy and effectiveness.

According to public information, Wuhan Keruidi Medical Products Co., Ltd. was established in 2012 and is mainly engaged in the production and sales of hemodialysis concentrates and dialysis powder. medical instruments After the registration certificate, the production of relevant dialysis powder was started in June 2016 and the liquid was brought to market.

On July 3, 2017, Guangdong Baolaite Medical Technology Co., Ltd., an A-share listed company, issued a capital increase announcement, which collectively used its own capital of approximately 12.38 million yuan to increase its capital, Kerui Di. After the transaction was completed, Bao Wright took up a 62.08% stake in Kerui Di. Received a loan to become a subsidiary of Paul Wright.