Another mechanical enterprise was ordered by the National Bureau to suspend production and rectification!

Medical Network August 21st, July 24-25, 2018, the State Drug Administration conducted a flight inspection of Qingdao Newba Yiou Optical Manufacturing Co., Ltd., and found 5 serious defects on the spot inspection:

In this regard, the State Council instructed the Shandong Food and Drug Administration to order the enterprise to immediately suspend production and rectification in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680), in violation of the Regulations on the Supervision and Administration of Medical Devices. And related laws Regulation Should be dealt with seriously according to law.

At the same time, enterprises are required to assess product safety risks. For those who may cause safety hazards, the relevant products should be recalled in accordance with the provisions of the “Administrative Measures for Medical Device Recalls”. The enterprise shall complete all the defects and rectify and pass the inspection and inspection by the provincial bureau before returning to production.

During the inspection, it was found that the company's quality management system mainly had the following defects:

The company used compressed air when injecting the lens preservation solution, but did not detect or monitor the compressed air purification effect, and did not meet the direct contact with the product use surface in the "Medical Device Production Quality Management Specification" and related appendix (hereinafter referred to as "Specification"). The degree of gas impact on the product should be verified and controlled to suit the requirements of the product being produced.

(1) The on-site process flow transfer card stipulates that the heating temperature of the heating plate is 80-95 °C, and the on-site check ML type adjustable electric heating plate (device number WD-03) only has the rotary knob to adjust the voltage, and there is no corresponding temperature display device. Can't confirm whether the temperature is within the control range, check another hot plate (device number WD-01), set the temperature value to 96 degrees Celsius, the actual heating temperature is displayed as 101 °C, beyond the temperature parameter control range, does not meet the specification. The enterprise shall prepare production process regulations, operation instructions, etc., and clarify the requirements of key processes and special processes.

(2) The enterprise fails to provide the batch production records with batch numbers 160227, 160226, 160518, and each batch (set) that does not meet the “Specifications” shall have a production record and meet the requirements for traceability.

(3) The company adopts the method of sterilization of the lens using damp heat sterilization, but the sterilization process of the enterprise is not carried out according to the sterilization confirmation plan, and the microbial load challenge test is carried out. The sterilization process in accordance with the “Code” shall be in accordance with the relevant standard Require confirmation before initial implementation, reconfirm if necessary, and maintain the requirements for confirmation of the sterilization process.

(1) The diameter specified in the technical requirements of the enterprise product, the measurement of the rear top power is carried out according to the method specified in GB/T11417. The national standard clearly stipulates that when the diameter is measured, the lens is placed in the measuring cell to maintain the temperature of the standard salt solution in the measuring pool. 20 °C ± 0.5 °C. Rotate the lens, measure the maximum and minimum diameters independently for 3 times'; after the top power measurement, 'the hydrogel lens is immersed in a standard salt solution of 20 °C ± 0.5 °C for at least 30 min before measurement' On-site verification of the company's measurement using normal temperature purified water instead of the standard salt solution, inconsistent with the technical requirements of the enterprise product. The performance indicators of the finished product inspection procedures provided by the enterprise have 5.5 aseptic requirements, 5.7 preservation liquid osmotic pressure, pumping out the factory test report (production Batch No. 20180720, 20180719) lacks sterility, preservation liquid osmotic pressure test item. Pumping factory inspection report (production batch number 20170518) The sterility test item is judged as qualified, but the corresponding original sterility test record is not provided, which does not comply with the "Specifications" The Chinese company 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 inspections. Call on or certificate.

(2) On-site inspection of the latest purified water (purified water is one of the components of the preservation solution) The full-performance testing time is July 10, 2018. The purified water detection reagent label provided by the company has only the product name, no grade, and the place of origin. Any other information such as the batch number, and the product name and material are inconsistent (if the product name is marked as sulfuric acid, and the actual bottle is white powdery solid), the process water should not be monitored and regularly tested, and the monitoring should be maintained. Record and test report requirements.

The enterprise has not distinguished the non-conforming products in the process inspection (such as falling off, untrievable products such as raw edges, and mixing them), and records the disposal records of non-conforming products (April 2 to July 2, 2018). The number of non-conforming products is 134,291. During the on-site inspection, check the statistical table of non-conforming products in the production process (April 2 to July 2, 2018), the total number is 211,298, the quantity does not match, and does not meet the requirements of the "Code" Non-conforming products shall be marked, recorded, isolated, reviewed, and corresponding measures shall be taken for non-conforming products according to the results of the review.

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 Shandong 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 Shandong Food and Drug Administration shall be required to enterprise To assess the safety risks of products, and to potentially 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 passed the follow-up review by the Shandong Food and Drug Administration, the production can be resumed. The Shandong Food and Drug Administration should promptly report the recall of the products and the resumption of production and resumption of production to the State Drug Administration.