The National Bureau ordered the two machinery enterprises to immediately suspend production and rectification!

Medical Network July 19th Recently, the State Drug Administration organized a flight inspection of Shanghai Weining Plastic Products Co., Ltd., Henan Yubei Weishi Materials Co., Ltd.

The flight inspection found that there were many serious defects in the production quality management system of the two enterprises. The State Drug Administration has instructed the Shanghai Food and Drug Administration, and the Henan Food and Drug Administration ordered the two enterprises to immediately suspend production and rectification.

After the company has completed the rectification of all the projects and has passed the follow-up review by the local provincial food and drug administration, it can resume production.

(1) The layout of the enterprise room is unreasonable. The dipping room in the 100,000-level clean area is set in the pouring room. People and logistics need to pass through the pouring room to enter. The company calls the dipping room for the pouring line. Automated transformation, irrespective of the production process of the product being inspected, does not comply with the "Medical Device Manufacturing Quality Management Regulations" and related appendices (hereinafter referred to as "Specifications"). The plants and facilities should be based on the characteristics of the products produced, the process flow and the corresponding cleanliness. The level requires reasonable design, layout and use requirements.

(2) The replacement time of the nitrogen filter of the enterprise has not been verified, and there is no record. It does not meet the gas in direct contact with the surface of the product in the Code. The degree of influence on the product should be verified and controlled to suit the products produced. Claim.

The company will suspend production and reconstruction from May 8, 2017 to July 8, 2017, and check the “Re-enablement of the comprehensive performance verification report of the purification workshop” before returning to production. The participating verification personnel have not been trained, and no ozone disinfection verification has been carried out, which does not meet the requirements. If the air purification system is turned on again after shutdown, the necessary tests or verifications should be carried out to confirm that the required cleanliness level requirements are still met.

In 2016, the company changed the raw rubber synthesis process, increased the film evaporation process, and designed and developed the “Standard Operation Procedure for Raw Rubber Synthesis”. The output list is not marked with the version number. The design and development output that does not meet the “Specifications” should be approved. Keep the relevant records required.

The cargo location card of a batch of medical silicone rubber in the enterprise is displayed on June 25, 2018, and the storage quantity is 45.36kg. The raw materials inspection report shows that the raw material quantity is also 45.36kg, but the inspection sample is 200g, among which 100g was sampled and the amount of waste was not displayed; the purchase contract showed the purchase by box, the quantity marked '1', no quality unit, and the purchase inspection order (kg) was inconsistent, and the procurement record in the “Code” should not meet the requirements. Traceability requirements.

(1) The original inspection procedure of the enterprise does not include the shell D4, D5, silicone gel small molecule residual material, edge angle inspection item, the enterprise revised the inspection procedure in June 2018, and the revised inspection procedure does not include the technical requirements of the product. 2.4 breast implant finished product performance 'edge angle' index, another silicone gel breast implant finished product inspection procedure stipulates that the shell and silicone gel D4, D5 items are commissioned once every 2 years, silicone gel breast The implant process inspection procedure stipulates that the silicone gel D4, D5 batches shall be commissioned and inspected, and the inspection procedures for the products shall be formulated according to the mandatory standards and the technical requirements of the registered or filed products. Inspection report or certificate requirements.

(II) Enterprise Product Release Audit Management Regulations 4.7.3.2 stipulates that the management representative shall sign the product release checklist to confirm whether the product is released, and check the release checklist of a certain batch of products. No manager's representative has signed, which does not comply with the “Specifications”. The enterprise shall stipulate the product release procedures, conditions and release approval requirements.

(3) The “Technical Regulations for Process Water Use” of the enterprise stipulates that “Before the water is used in the workshop, the quality control department shall sample and test the purified water in advance, and the qualified water may be used before.” Check the batch records. The final cleaning time is March 16, 2018. Failure to provide the water quality monitoring record before use, does not meet the requirements of the Code for monitoring and regular inspection of process water, and maintaining monitoring records and test reports.

The enterprise has confirmed the defects of the above quality management system. The above behavior of the enterprise does not comply with the relevant regulations of the medical device production quality management regulations, and the production quality management system has serious defects. The State Drug Administration is responsible for the Shanghai Food and Drug Administration. The company was ordered to immediately suspend production and rectification, and it was seriously dealt with in violation of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680) and related laws and regulations. It also instructed the Shanghai Food and Drug Administration to require the enterprise to assess product safety risks. For those who may cause safety hazards, the relevant products shall be recalled in accordance with the Measures for the Administration of Medical Device Recall (Order No. 29 of the State Food and Drug Administration).

After the company has completed the rectification of all the projects and has passed the follow-up review by the local provincial food and drug administration, it can resume production.

Notice of the State Drug Administration on Suspension and Rectification of Henan Yubei Weishi Materials Co., Ltd.

Recently, the State Drug Administration organized a flight inspection of Henan Yubei Weishi Materials Co., Ltd. During the inspection, it was found that the company's quality management system mainly had the following defects:

The company is not equipped with a disposable sterile vaginal dilator. equipment , unable to carry out the testing of the project, does not meet the "Medical Device Manufacturing Quality Management Regulations" and related appendices (hereinafter referred to as "Specifications") enterprise It shall be equipped with inspection instruments and equipment that are compatible with the product inspection requirements. The main inspection instruments and equipment shall have clear operating procedures.

The raw material change of the enterprise has not carried out product safety, effectiveness and risk evaluation. The design and development materials of the disposable sterile vaginal dilator only involve the raw material 'polypropylene'. The actual production involves raw materials such as polypropylene, polystyrene and polyphenylene. Vinyl resin, does not meet the materials selected in the Code, changes in the function of parts or products may affect the safety of medical device products. When it is effective, it should evaluate the risks that may be caused by the changes, and take measures to reduce the risk if necessary. To an acceptable level, it should be relevant Regulation Requirements.

The raw material polypropylene purchased by the enterprise for one-time use of sterile vaginal dilator, the storage receipt on January 21, 2018, the supplier name is not recorded in the inbound and outbound records, the product batch number, the purchase record cannot be traced, and the procurement in the Code is not met. Records should meet traceability requirements.

(1) In the production record of the medium transparent shaft rotary expander of the enterprise batch number 71707011, the production order, the material name in the picking list is only recorded as 'granules', and it cannot be confirmed that it is polypropylene, polystyrene or the like, and The batch number is not recorded in the picking list. The batch number 71803009 has two batch production records, one quantity is 6900, one part is 18000/60 pieces, “One-time use sterile vaginal dilator operation instruction book” (YB /003—2014) In the '100 kg of new pellets can be added to the crushed material 20 kg', the batch production record can not confirm whether the addition and addition ratio, does not meet the "Specifications" in each batch (set) products should have production Record and meet traceability requirements.

(2) The company's ethylene oxide addition and sterilization verification report is inconsistent. In 2015, the "single-use sterile vaginal dilator sterilization verification report" in the sterilization agent injection amount is 16kg ± 0.5kg, 2018.6.9 dilator The sterilization record showed that the amount of ethylene oxide was 15kg, and the sterilization record of the batch number 71804002 dilator was not found. The sterilization process control document should be formulated in accordance with the “Specifications”, and the sterilization process parameter records of each sterilization batch should be maintained. The sterilization record should be traceable to the requirements of each production batch of the product.

(1) The factory inspection report issued by the enterprise for the one-time use of sterile vaginal dilator is 'conformity resistance'. The items are all 'conforming to the requirements'. The original record of the project inspection is not seen. The 2018 production expander batch inspection record, batch number 71804002, 71805002 product inspection report is based on 'YY 0336-2002' (current version is YY 0336-2013), batch number 71803009, 71806003 product inspection report is based on 'product technical requirements', product technical requirements for sterile test method GB/ T14233.2—2005, YY 0336—2013 The sterility test method is “Chinese Pharmacopoeia”, which does not comply with the “Specifications”. The enterprise shall formulate the inspection procedures for the products according to the mandatory standards and the technical requirements of the products registered or filed, and issue corresponding Inspection report or certificate requirements.

(2) The one-time use sterile vaginal dilator (medium shaft type) of enterprise batch number 71806003, has completed the inspection and issued the factory inspection report without any sterilization, and the product release record, the batch of products produced a total of 15000 / 50 boxes In the outsourcing room, 13 boxes (300 per box) were packed and sealed, and there was no ethylene oxide sterilization chemical indicator card and ethylene oxide sterilization certificate. The release records of the batch showed 'quantity: 15000, extinguished Bacterium time: 2018.06.09, Approval date: 2018.6.25, Conclusion: Release ', the factory inspection report date is June 25, 2018, the conclusion is 'this product is tested according to the technical requirements of disposable sterile vaginal dilator, the result Meet the requirements', does not meet the requirements of the "Regulations", the enterprise should stipulate the product release procedures, conditions and release approval requirements.

(3) Purified water microbiological limit test The 'test date' 'report date' 'sampling location' in the original record is not filled, the medium used, culture time, culture temperature are not in accordance with the requirements of the 2015 edition of the Chinese Pharmacopoeia, but the test report The inspection is based on the 2015 edition of the Chinese Pharmacopoeia, which does not meet the requirements of the Code for monitoring and regular inspection of process water, and maintaining monitoring records and test reports.

The enterprise has confirmed the defects of the above quality management system. The above behavior of the enterprise does not comply with the relevant regulations of the medical device production quality management regulations, and the production quality management system has serious defects. drug The Supervisory Authority instructed the Henan Food and Drug Administration to order the enterprise to immediately suspend production and rectification, and to violate themedical instruments The Regulations on Supervision and Administration (Order No. 680 of the State Council) and related laws and regulations shall be dealt with severely according to law. At the same time, the Henan Food and Drug Administration shall be required to assess the safety risks of the products, and shall be in accordance with the medical treatment. Regulations on the Administration of Device Recall (Order No. 29 of the State Food and Drug Administration), recall related products.

After the company has completed the rectification of all the projects and has passed the follow-up review by the local provincial food and drug administration, it can resume production.

Attachment: Notice of Flight Inspection for Shanghai Weining Plastic Products Co., Ltd.

Attachment: Notice of Flight Inspection of Henan Yubei Weishi Materials Co., Ltd.