CFDA and fly examination, the two medical equipment company suspended production for rectification

Pharmaceutical Network December 20 News December 18, CFDA released a flight inspection announcement, the two medical device companies were suspended for rectification, the following details:

Recently, the State Food and Drug Administration organized an inspection on Hubei Sunshine Shenqi Medical Technology Co., Ltd. During the inspection, it was found that the quality management system of the enterprise mainly has the following defects:

Enterprises can only provide records of the use of laser power meters, medical leakage current testers and ground resistance meters of July 2016. They fail to provide records of the use of the above three testing instruments at other times and can not provide the above testing equipment. Calibration, maintenance and repair records, and does not meet the "medical device manufacturing quality management practices" and the relevant appendix (hereinafter referred to as "the") should establish the use of test equipment and equipment records, records, including the use, calibration, maintenance and repair Situation requirements.

The raw materials of the purchased optical fiber of the enterprise do not meet the requirements of the registered product standard YZB / State 4336-2103 and the specification. The registered optical fiber standard length of the product is 5000mm ± 10% and the diameter of the core is 0.6mm ± 10%. The actual purchased optical fiber length 2500mm, core diameter 0.4mm, failed to provide records of the risks due to alteration, and did not meet the requirements of the Code. Enterprises should identify and keep records of the changes in design and development. If necessary, Develop changes to be reviewed, validated and validated and approved prior to implementation.

Enterprise procurement requirements for raw materials optical fiber is not clear Acceptance criteria, procedures, drawings, procurement does not meet the "standard" procurement should be clear, clearly stated procurement requirements, including procurement of goods category, acceptance criteria, specifications, specifications, drawings and other content Request.

Enterprise aging test is not prepared operating instructions, does not meet the "standard" enterprises should prepare production procedures, operating instructions, etc., a clear key processes and special process requirements.

5.2.2 Indicator Output Power, 5.3 Laser Power Indicator, 5.4 Laser Output Control, 5.5 Laser Beam Transmission System Efficiency, 5.6 Laser fiber optic transmission system for factory inspection, does not meet the "standard" in accordance with the mandatory standards and enterprises should be registered or filing product technical requirements for the development of product testing procedures, and issue the appropriate inspection reports or certificate requirements.

The enterprise did not reflect the information of the nonconforming product in the "Nonconforming Product Processing Sheet" on Feb. 27, 2014 and directly condemned the concession for acceptance. If the catheter gasket (product code: YG-100A-00-046) is damaged, The lower shaft bracket (product number: YG-100A-00-017) is wrong in size. The welding of the machine bracket (No. YG-100A-00-015) is not firm, and the non- standard products in the " Record, isolate, review, according to the results of the review, the non-conforming product to take the appropriate measures to deal with the request.

The enterprise fails to organize the appraisal in accordance with the frequency of the appraisal as stipulated in Article 4.1.1 of the "Management Review and Control Procedure" (Document No. YG-2-027) and the content of the appraisal as stipulated in Article 4.2, and the appraisal of the appraisal conducted according to Article 4.2 of the " , Quality management system evaluation and review to ensure its continued suitability, adequacy and effectiveness of the request.

The enterprise has confirmed the defects of the above quality management system.

The above behavior of the enterprise does not conform to the relevant provisions of the medical device manufacturing quality management standard, and the production quality management system has serious defects. The national food drug Supervision and Administration Bureau ordered Hubei Food and Drug Administration ordered the enterprise to immediately stop rectification according to law,medical instruments Supervision and Management Ordinance "(State Council Order No. 680) and related laws and regulations, according to the law seriously.

At the same time instructed Hubei Food and Drug Administration requirements enterprise Assessment of product safety risks, may lead to potential safety problems, should be in accordance with the "Medical Device Recall Measures" (SFDA Order No. 29), the recall of related products.

Until the completion of rectification and rectification by the provincial food and Drug Administration where the track after passing the review before resumption of production.

Recently, the State Food and Drug Administration organized an inspection of Inner Mongolia Ai Zhong Medical Imaging Co., Ltd. During the inspection, it was found that the quality management system of the enterprise mainly has the following defects:

(A) of the purified water system is set in the 100,000 production area, and the distribution of fluid connectivity; clean area is not set weighing area, one hundred thousand bottles blowing between the condensing air dryer unit and the compressed air front filter device , Hung on the wall between the blowing bottle has been deactivated wall-mounted air-conditioning, cleaning containers without set containers, does not meet the "medical device manufacturing quality management practices" and related appendices (hereinafter referred to as the "Code") plant should be Meet the production requirements, production, administration and support of the overall layout of the district should be reasonable and shall not interfere with each other's requirements.

(2) The enterprise is not equipped with the positive control test room and biological safety cabinet required for the test, and no membrane filter device for the purifying water test, and the enterprise that is not in conformity with the "Standard" shall be equipped with the product scale, variety and inspection requirements The inspection sites and facilities requirements.

Administration of the product registration certificate (国家 注准 20163310357) in the composition of food grade liquid paraffin, and the actual business procurement is medicinal Accessories Light liquid paraffin, no record of review, validation and validation of product design changes does not meet the requirements of the Code in identifying and keeping a record of changes in design and development and, where necessary, design and development changes Review, verify and confirm, and get approval before implementation.

The enterprises did not sign the quality agreement with liquid paraffin suppliers and PET preform suppliers, and did not meet the requirements of the "Regulations" that enterprises should sign quality agreements with major raw material suppliers and clarify the quality responsibilities assumed by both parties.

Enterprise ultra-high temperature instantaneous sterilizer operation SOP (TF / AZ7.5.1-02), the ultra-high temperature instantaneous sterilization temperature of 120-135 ℃, time 5 ± 1 seconds, the company did not confirm the ultra-high temperature instantaneous sterilization parameters, Enterprises that do not conform to the "Regulations" should confirm the special process of production and keep the records, including the requirements for confirming the plan, confirming the method, operating personnel, evaluating the result, and re-confirming.

In the finished product testing SOP (TF / AZ 8.2.4-01), 4.5.4 Escherichia coli test method using plate test, and the approved product technical requirements of microbial limit check, according to the 2010 edition of "Chinese Pharmacopoeia" in the micro-organisms Limits of detection methods are inconsistent, purified water test SOP (TF / AZ 7.5.1-16) microbial limit test 4.4.2 using the plate test, and the 2015 version of "People's Republic of China Pharmacopoeia" in the detection of purified water limits microbial limits Inspection should be inconsistent with the membrane filtration method, does not meet the "standard" in accordance with mandatory standards and enterprises should be registered or filing product technical requirements for the development of product testing procedures, and issue the appropriate inspection reports or certificate requirements.

The records of nonconforming products of the enterprise showed that there were 2 bottles in the production process of lot number 201708004 and were scorched by scrap, and no nonconforming product was judged and judged. In the batch record of product (lot 201708004), the nonconforming product was zero and did not conform to The "standard" enterprises should be non-conforming product identification, recording, isolation, review, according to the results of the review, the non-conforming product to take appropriate measures for the disposal of the request.

The enterprise has confirmed the defects of the above quality management system.

The above behavior of the enterprise does not conform to the relevant provisions of the medical device manufacturing quality management standard, and the production quality management system has serious defects. The State Food and Drug Administration ordered the Food and Drug Administration of Inner Mongolia Autonomous Region to order the enterprise to immediately suspend production for rectification according to law, Machinery Supervision and Management Ordinance "(State Council Order No. 680) and related laws Regulations , According to the law seriously.

At the same time instructed Inner Mongolia Autonomous Region Food and Drug Administration to require the company to assess product safety risks, may lead to potential safety problems, should be in accordance with the "Medical Device Recall Management Measures" (SFDA Order No. 29) recalls Related Products.

Until the completion of rectification and rectification by the provincial food and Drug Administration where the track after passing the review before resumption of production.