CCTV News: According to the website of the State Drug Administration, the State Drug Administration organized an inspection team to conduct a flight inspection of Hunan Sanrui Biotechnology Co., Ltd. and found that the company's quality management system had serious defects.

1. Institutions and personnel

The site requires enterprise inspection personnel to perform the finished product inspection items of disposable infusion disinfection joint products "base matching" and "separation force inspection". In actual operation, the inspection equipment parameters set by the inspectors are inconsistent with the inspection parameters stipulated in the "Internal Control Standard for Disposable Infusion Disinfection Joints" of the enterprise. The inspectors of the enterprise are not familiar with the product inspection requirements and do not comply with the "Medical Device Production Quality Management Standards" (hereinafter referred to as the "Specifications") that those engaged in product quality in enterprises should undergo training that is in line with their job requirements and have relevant theoretical knowledge and practical operation skills.

2. Equipment

Enterprise does not equip ultrasonic welding equipment and negative pressure suction devices required for the production and inspection of "disposable impulse and puncture sets", which does not comply with the requirements in the "Code" that enterprises should be equipped with production equipment, process equipment, etc. that match the products and scale they produce, and ensure effective operation.

3. Procurement

Check the purchase acceptance status of a batch of aluminum foil raw materials in the enterprise on-site. The enterprise provided two inspection reports with different numbers and related inspection results, and neither report contained all inspection items specified in the enterprise aluminum foil raw material acceptance standards; the numerical range requirements of the enterprise disposable infusion disinfection joint base inspection report and the "open outer diameter" reception criteria stipulated in the acceptance standards of the enterprise, and the actual numerical values ​​in the inspection record meet the requirements of the inspection report acceptance criteria, but do not meet the above acceptance standards; the actual numerical values ​​of the "size side length" in the inspection record of the enterprise disposable infusion joint sponge do not meet the requirements of the enterprise acceptance criteria. The above circumstances do not comply with the relevant requirements of the "Code" that enterprises should establish procurement control procedures to ensure that the purchased items meet the prescribed requirements and are not less than the relevant requirements of the relevant provisions of laws and regulations and national mandatory standards.

4. Production management

The enterprise moved to a new production address in May 2024, but the system documents did not specify the requirements for confirming key processes after changes in the factory and facilities, nor did it confirm the key processes of assembly of disposable infusion disinfection joints, which did not comply with the requirements in the "Specifications" that enterprises should prepare production process regulations, operation instructions, etc., and clarify the requirements of key processes and special processes.

5. In terms of quality control

The isopropanol content detection methods and judgment standards stipulated in the internal control indicators of disposable infusion disinfection joint products of enterprises are inconsistent with the provisions in the product technical requirements, and do not comply with the requirements in the "Specifications" that enterprises should formulate product inspection procedures based on mandatory standards and registered or registered product technical requirements, and issue corresponding inspection reports or certificates.

VI. In terms of sales and after-sales service

Spot check the inventory ledger of some batches of finished products in the enterprise. The ledger record is inconsistent with the actual inventory in the enterprise warehouse and does not comply with the "Specifications" that enterprises should establish product sales records and meet traceability requirements.

7. In terms of unqualified product control

On-site inspection found that there were unqualified semi-finished products stored in the assembly workshop of the enterprise, but the quantity of unqualified products in the corresponding production cycle was not recorded in the corresponding batch production records of the enterprise, nor did the above-mentioned unqualified semi-finished products be reviewed and disposed of in accordance with the requirements of the enterprise's "Unqualified Product Control Procedure" and did not comply with the requirements of the "Specifications" that enterprises should mark, record, isolate, and review the unqualified products, and based on the evaluation results, corresponding disposal measures are taken for the unqualified products.

The enterprise quality management system has serious defects and does not comply with the relevant requirements of the "Specifications". The enterprise has confirmed the above problems.

In response to the problems found in the above inspection, the Hunan Provincial Drug Administration shall, in accordance with Article 72 of the "Medical Device Supervision and Administration Regulations", take control measures to order production suspension in accordance with the law, and carry out supervision and random inspections if necessary; for suspected violations of the "Medical Device Supervision and Administration Regulations" and relevant provisions, deal with them in accordance with the law; for enterprises to evaluate product safety risks, and for those that may lead to safety hazards, the relevant products shall be recalled in accordance with the provisions of the "Medical Device Recall Management Measures"; after the enterprise completes the rectification of all defective projects, production can only be resumed after the Hunan Provincial Drug Administration passes the review.