The State Drug Administration piloted the inspection and the two medical and pharmaceutical companies were suspended from production and rectification.

Medical Network June 20 hearing There are two other medical device manufacturing companies that have been inspected by the state and issued an announcement yesterday.

This is after the official website of the new State Food and Drug Administration officially launched on March 21 this year. medical instruments The company issued a reorganization notice in the inspection.

The State Food and Drug Administration announced that it had stopped production and reform of the Lanzhou Rongguang Denture Production Center. enterprise The following defects exist in the quality management system:

There is no place store card for material in the warehouse of the enterprise, no material management ledger, no record of raw material inventory quantity, which does not meet the “Medical Device Manufacturing Quality Management Specification” and related appendix (hereinafter referred to as “the specification”). The storage area should be able to satisfy the raw materials and packaging materials. The storage conditions and requirements for intermediate products, products, etc. shall be stored separately according to conditions such as test, qualification, failure, return or recall, etc. to facilitate inspection and monitoring.

The custom-designed all-ceramic fixed denture design and development output provided by the company has not been reviewed according to the design control program. The output of the design and development that does not comply with the “Specifications” should be approved, and the relevant records must be maintained.

(1) The enterprise procurement control procedure (No. Q/RG G02.07-201) does not include the re-evaluation requirements of qualified suppliers. If the company does not comply with the “Regulations”, the company shall establish procurement control procedures to ensure that the purchased items meet the specified requirements, and Not below the law Regulation Relevant requirements of relevant regulations and national mandatory standards.

(2) To check the supplier assessment form of a company, the production department, the quality and technology department of the company that issued the review opinions, and the approval person are not signed, and the date is not indicated. The supplier of denture raw materials that does not meet the requirements in the “Code” should be legally qualified. Verify and save the supplier qualification documents, and establish file requirements.

(a) The product registration certificate number on the fixed dentures used in May 2018 has expired (Guang Shi Yao Xuan (2014) No. 2014 No. 2630008), and the current valid product registration number is not printed. It does not comply with the "Regulations". The product instructions and labels shall comply with the requirements of relevant laws, regulations and standards.

(II) The flow chart of the company's custom-made all-ceramic fixed denture does not specify the model into the factory disinfection Procedures; Dental Imprints, Oral Models and Finished Product Sterilization Work Instructions (No. RG-2016-002) Regulations: Ozone and Ultraviolet Disinfection 20-30 minutes, Onsite inspection, No ozone and UV disinfection equipment, Not in compliance with "Specifications" should specify the method of disinfection of oral impressions, oral models and finished products, and the requirements for disinfection in accordance with the requirements.

(3) The enterprise has not checked the material balance of the main denture raw materials, and does not meet the requirement of material balance check for the main denture raw materials in the “Specifications”.

The company cannot provide the acceptance record for a company's batch number of 17002125 base paste in accordance with the “Regulations for Inspection of Custom Denture Raw Materials Entering the Factory” (RG/GY-03-2016). Each batch (table) product that does not meet the “Specifications” should have Inspection records, and meet the requirements of traceability. Inspection records should include the requirements for incoming inspection, process inspection and inspection of finished product inspection, inspection report or certificate.

The company did not perform user surveys in accordance with the “Accidents Monitoring and Reporting System” (RG/G-07-2016), and did not keep records of adverse event collection, processing, and evaluation. Inconsistent with the “Code,” companies should designate relevant departments to take over and investigate. , Evaluate and handle customer complaints, and maintain relevant record requirements.

The company did not stipulate the management of the sales unit, did not establish a complete sales unit file, did not collect the certification documents of the medical organization of all sales units, and checked the sales unit record with the order number RG180502396. The company could not provide the processing agreement and qualification certificate of the sales unit. , It does not comply with the "standard" should choose to have a legal qualification of medical institutions, preservation of medical institutions practice qualification certification documents, and establish the file requirements.

The enterprise did not sterilize the product returned by the medical institution, and the review was conducted in accordance with the requirements of the assessment. The company did not comply with the requirements in the "Code" that the company should disinfect the product returned by the medical institution.

The State Food and Drug Administration found out during the flight inspection of Hubei Xianming Medical Devices Co., Ltd. that the company's quality management system mainly had the following defects:

The layout of the company's cleanroom layout is unreasonable. The 300,000-class cleanroom is equipped with an auxiliary living room. There is no need for dust removal facilities in the 100,000-grade cleanroom, and the floor area is dirty. Many wire and wall joints , No reliable sealing, Dangerous goods and unqualified goods in the first floor and the second floor of the elevator room, Not in compliance with the "Medical Device Manufacturing Quality Management Specification" and its appendix (hereinafter referred to as the "Code"). Plants and facilities should be based on the characteristics of the products produced. , The process flow and the corresponding cleanliness level require reasonable design, layout and use requirements.

(1) The new air outlet cleaning and replacement operation of the air purification system of the company is inconsistent with the requirements of the document for the control of the process control; the initial efficiency of the air purification system is not monitored, the initial pressure difference between the intermediate efficiency and the real-time pressure difference; the recertification cycle of the air purification system is not clear, and the verification data The environmental monitoring data is not clearly dynamic or static; The air purification system does not run continuously, and restarts after 30 minutes of daily shutdown after production. No verification or testing is performed. The clean room (area) air purification system that does not meet the “Code” should be confirmed And maintain continuous operation, maintain the corresponding cleanliness level, and reconfirm after a certain period of time. If the air purification system is turned on again after shutdown, the necessary tests or verification shall be performed to confirm that the required cleanliness level requirements can still be met. Claim.

(2) The enterprise's process water documents do not clearly indicate the requirements for pollution prevention measures such as identification of the end-of-pipe cleaning water transmission pipelines, injection water-making equipment and circulation of pipelines, etc., and do not comply with the “Regulations” in which enterprises should establish process water management documents. Process water storage tanks and pipelines should meet product requirements, and be cleaned and disinfected on a regular basis.

(1) The company's shredder workshop uses masterbatch without lot number and no purchase record; the raw material storehouse is ABS injection plastic, and the HDPE batch number is inconsistent with the record of purchase inspection report of the purchased material; stainless steel capillary, masterbatch and toner are all not available. Inclusion in the company's procurement list, does not meet the requirement of traceability requirements in the procurement records of the "Code".

(2) The audit records of the enterprise suppliers are incomplete, and the qualified supplier catalogs in 2016 and 2017 are not retained. The enterprises shall not meet the requirements in the “Regulations” that the company shall establish a supplier auditing system and shall conduct audit and evaluation of suppliers.

(1) In the key processes such as injection molding, extrusion molding, and blow molding in the technological process of the company, the parameters such as the proportion of reusable materials added and the allowed number of parameters have not been verified or confirmed, and the company does not comply with the “Regulations”. Procedures, work instructions, etc. Clear requirements for critical processes and special processes.

(II) The process parameters in the final cleaning procedure for needles are inconsistent with the verification conclusions in the Process Confirmation Report for the Final Cleaning Process of the Needle (XM/JS-JZ.MDQX.BG: 2016), and do not conform to the production process in the “Specifications”. Where it is necessary to clean raw materials, intermediate products, etc., the cleaning methods and requirements shall be clarified, and the requirements for verification of the cleaning effect shall be verified.

(III) The enterprise did not clear the site according to the regulations, the workers produced the onsite cleaning turnover box in the injection molding workshop, the ultrasonic cleaning machine of the 100,000 level cleaning room of the needle tube workshop had the sewage after the last use, the clearance requirements in the clearance records and the “clean area working environment management The regulations for clearing the clearing grounds in the “cleanliness system” are inconsistent with the management provisions for clearing grounds that should be established in the “Regulations” to prevent cross-contamination of products, and to do a good job of clearing records.

(4) The company's multi-batch intermediates are stored in clean workshops and aisles, and the storage conditions and time are not verified. Enterprises that are not in conformity with the “Regulations” should be based on product quality The degree of influence stipulates the storage conditions of various aseptic medical device products and materials. The storage site shall have corresponding environmental monitoring facilities. The storage conditions shall be controlled and recorded. The storage conditions shall be specified in the label or instruction manual.

The State Food and Drug Administration announced that the company had confirmed the defects in the above-mentioned quality management system. The bureau instructed the provincial drug administration department of the company to order the company to immediately stop production and rectification, and wait until the company completes the entire project rectification and tracked by the provincial drug administration department. Only after review can resume production.