Two other medical device companies were ordered by the National Bureau to stop production immediately!

Pharmaceutical Network October 23rd Following two weeks ago, the State Food and Drug Administration issued a flight inspection announcement. After all four medical device companies stopped production, today they announced the results of the two flight inspections, and all were also required to suspend production and rectification.

On October 22, the official website of the State Food and Drug Administration issued a flight inspection announcement. In the compliance inspection of the “Quality Management Standards for Medical Device Production”, the two companies that were inspected by Tianjin Weiwa Dengtai Technology Co., Ltd., Nanjing Yigao Microwave System Engineering Co., Ltd. was required to stop production and rectification due to a number of major defects.

On October 11, the State Food and Drug Administration issued a flight inspection report for four medical device companies. Due to major defects in all four companies, production was rectified. In less than half a month, all six companies that were inspected were shut down. Rectification.

Compared with the flight inspection before September, one signal is that the State Food and Drug Administration has become more and more strict on the supervision of medical device GMP. Some subtle but significant production defects have been discovered. All the enterprises that have passed the inspection have requested to suspend production and rectification. It’s not a rare thing.

Attached are two notices of suspension of production issued by the State Food and Drug Administration today.

First, equipment aspects

Material weighing is not equipped with suitable weighing equipment. For example, in warehouse 1, the material placement mode of the transformer is not packed densely, and some transformer insulation layers are scratched, and the number of stainless steel strips in and out of the warehouse is checked. Weighed by the weighing method, it was found that the stainless steel strip was drooped to the ground during the verification and could not be accurately weighed.medical instruments Production Quality Management Regulations (hereinafter referred to as "Specifications") enterprise Appropriate measuring instruments shall be provided. The measuring range and accuracy of the measuring instruments shall meet the requirements for use. The measuring instruments shall indicate the validity period of the calibration and the requirements for keeping the corresponding records.

Second, design and development aspects

The enterprise HF systolic system bipolar condensing mode power output is changed from 0-120W to 0-80W, and the confirmed design change materials are not provided. The enterprises that do not meet the "Specifications" should identify and keep records of design and development changes. Requirements.

Third, production management

On-site verification of high-frequency electric knife (No. 16121506), the company failed to provide relevant production inspection records, can not be traced, does not meet the "Specifications" in each batch (table) products should have a production record, and meet the requirements of traceability.

Fourth, quality control

The enterprise failed to make the factory inspection procedures and inspections in strict accordance with the national compulsory standards. The high-frequency leakage current test load resistance of 200 ohms is required in GB9706.4, the test resistance is 200 ohms, the line spacing is 50 cm, and the load resistance of the test personnel is 400 ohms. The resistance is 200 ohms, the line spacing is 25cm for testing. During the production process, the cable withstand voltage test is checked. The operating procedure requires 10s to rise to 1000V for 1min. Actually, it is 20s to 1000V for 40s. In the finished product inspection, the high frequency leakage current test Require 10s to rise to 1000V, keep 1min, actually rise to 4000V in 18s, keep 42s, do not meet the "Specifications" in the enterprise should be based on mandatory standards and registered or filed product technical requirements to develop product inspection procedures, and issued corresponding Inspection report or certificate requirements.

Nanjing Yigao Microwave System Engineering Co., Ltd. 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 Bureau instructs Jiangsu. The Provincial Food and Drug Administration ordered the enterprise to immediately suspend production and rectification in violation of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680) and related laws. Regulation At the same time, the Jiangsu Food and Drug Administration is required to require the enterprise to assess the product safety risks. In case of potential safety hazards, it should be in accordance with the “Administrative Measures for Medical Device Recall” (Order of the State Food and Drug Administration) No.), recall related products.

After the company has completed the rectification of all the projects and has passed the follow-up inspection by the Jiangsu Food and Drug Administration, the production can be resumed.

announce.

First, institutional and personnel aspects

The company appointed the management on May 1, 2017, but its actual work is sales and R&D. The company has not taken measures to improve employees' awareness of meeting the requirements of the quality management system, and does not comply with the "Quality Management Regulations for Medical Device Production" (hereinafter referred to as " The management representative is responsible for establishing, implementing and maintaining a quality management system, reporting on the operation of the quality management system and improving the requirements, and raising the awareness of employees' awareness of regulations, regulations and customer requirements.

Second, equipment aspects

The enterprise has not configured the equipment for detecting X-ray radiation project, nor has it commissioned the inspection. It does not meet the requirements of the “Code”, and the inspection equipment and equipment that should be equipped with the product inspection requirements. The main inspection instruments and equipment should have clear operating procedures. Claim.

Third, design and development aspects

The product design and development output data of the enterprise does not include the product formula, and does not include the following performance index requirements in the technical requirements of the product: X-ray resistance, tensile bond strength, shear bond strength, composition and percentage, not in conformity with the specification. The design and development output of the enterprise should meet the input requirements, including purchase , relevant information required for production and service, product technical requirements, etc.

Fourth, production management

(I) Enterprise Process Flow Chart (SC-SOP-01, Edition B/2017) The specified process is: Raw Material Purchasing - Inspection - Broken Material - Lathe Processing - Polishing - Curing - Cleaning - Inspection - Packaging - Storage, Enterprise Change The actual production process is lathe processing-breaking, un-breaking process specification and operation instruction, spot check production record (JL-7.5-03, fiberglass pile, specification model VIVAdental-V3, production batch number 180608). The production process is changed as follows: Cleaning-curing, not in compliance with the "Code", enterprises should prepare production process specifications, work instructions, etc., to clarify the requirements of key processes and special processes.

(2) Random inspection of the company's production record (JL-7.5-03, fiberglass pile, specification model VIVAdental-V3, production batch number 180608), unrecorded batch quantity, process parameters, main equipment, not in compliance with each batch of the Code Products should have a production record and meet traceability requirements.

V. Quality control

The company's product inspection procedures do not cover the following performance indicators in the registered product technical requirements: bending properties, flexural modulus, X-ray resistance, tensile bond strength, shear bond strength, composition and percentage The enterprise shall not comply with the mandatory standards and the technical inspection requirements of the products registered or filed in accordance with the "Code", and issue the corresponding inspection report or certificate requirements.

Tianjin Weiwa Dengtai Biotechnology Co., Ltd. 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 has instructed The Tianjin Municipal Market and Quality Supervision and Administration Commission ordered the enterprise to immediately suspend production and rectification according to law, and severely deal with violations of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680) and related laws and regulations. At the same time, it instructs Tianjin market and quality. The supervisory and management committee requires the enterprise to assess the product safety risks. For those who may cause safety hazards, the relevant products should be recalled in accordance with the Regulations on 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 been tracked and reviewed by the Tianjin Municipal Market and Quality Supervision and Management Committee, the production can be resumed.

announce.