The State Food and Drug Administration notified three medical device manufacturers of flight inspections

Medical Net News, June 5 Recently, the State Drug Administration notified the results of flight inspections to Chongqing Xinwen Medical Devices Co., Ltd., Changsha Jingtong Medical Devices Co., Ltd. and Hainan Taihe Medical Technology Co., Ltd., three medical device manufacturers.

Notice of the State Drug Administration on the Discontinuation of Production of Chongqing Xinwen Medical Devices Co., Ltd.

Recently, the State Drug Administration organized a flight inspection of Chongqing Xinwen Medical Devices Co., Ltd. During the inspection, it was found that the company's quality management system mainly had the following defects:

The 37°C water baths (numbers SYG-01, SYG-02) that the company tested for recovery performance have not been calibrated, and are not in compliance with the “Medical Device Manufacturing Quality Management Specification” (hereinafter referred to as “the Code”). Enterprises should establish inspection instruments and equipment. The use of records, including the use of records, calibration, maintenance and repair requirements.

The registered product standard “Shape memory ribs embracing plate” (YZB/Guo 1106-2011) has a 4.1.2 phase change temperature (Af value) requirement of 29±3°C. The phase change temperature requirement in the TiNi-Mg alloy quality technology agreement is 'Af=33±3°C', and the phase change temperature value (Af) provided by the supplier in the product quality certificate is also 33±3°C. Changes in the temperature-changing requirements of the review records are inconsistent with the “Code” where the company shall identify and maintain records of design and development changes. When necessary, design and development changes shall be reviewed, verified and confirmed, and approved before implementation. The request.

The company did not conduct on-the-spot investigations and kept records of the primary supplier 'A Material Co., Ltd.' of the Ti-Ni-Mg alloy memory plate in accordance with the “Procurement Control Procedures” (XWQM/B-10-00/0). Enterprises that do not comply with the "Regulations" shall establish a supplier auditing system and shall conduct audits and evaluations on suppliers. When necessary, on-site audits shall be conducted.

(1) On-site inspection of the key processes in the company's "Key Operation Procedures for Memory Processing" (XWQM/C1-ZY-SOP-03 00/0 Edition) effective on December 15, 2017, temperature, time and other heat treatment parameters and original versions The temperature and time parameters of the documents have undergone major changes, but no verification reports and verification records of the changed parameters have been found. Enterprises that are not in conformity with the “Regulations” shall prepare production process rules, work instructions, etc., and define key processes and special processes. Claim.

(II) The company failed to provide the parameter records of the key process (product memory heat treatment) of the shape memory rib encircling bone plate with batch number 170617 (Model JLG6H12-65), which does not meet the requirements of the "Specifications" for each batch (table) product. Record, and meet the requirements of traceability requirements.

Random inspection of lot production records for product lot number 170617 (Model JLG6H12-65) and product lot number 161117 (Model JLG4H14-45). The company did not perform 'H' diameter measurement on semi-finished products, and did not perform a deviation of 30% of the sample volume. Record; Product registration standard "Shape memory ribs embracing plate" (YZB/Guo 1106-2011) 4.3.1 Finished surface defects and 4.5.2 recovery performance are 100% factory inspection items, but failed to provide the relevant products of the above batch number Inspection original records, which do not meet the requirements of the traceability requirements for each lot (table) product in the “Specifications”.

The company has not collected the blood/urine nickel ion concentration data according to the requisition content of the registered registration form for approval, conducted a long-term follow-up study on each product implanted clinically, and paid attention to the safety of nickel ion precipitation, and conducted statistics. Analysis, inconsistent with the "Code", enterprises should establish data analysis procedures, collect and analyze data related to product quality, adverse events, customer feedback and quality management system operations, verify product safety and effectiveness, and maintain relevant records requirements.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the company does not comply with the relevant provisions of the medical device manufacturing quality management standard. The production quality management system has serious defects, and the State Drug Administration supervises the Chongqing Food and Drug Administration. The company shall be ordered to suspend production and rectification immediately in accordance with the law, in relation to violations of the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680) and related laws. Regulation , Strictly deal with according to law. At the same time, the Chongqing Food and Drug Administration is required to require the company to evaluate product safety risks. If it is likely to cause potential safety problems, it shall follow the “Measurement of Medical Device Recall Management” (Order of the State Food and Drug Administration 29 No.) stipulates that recall related products.

After the company completes the rectification of all the projects and is followed by the local Food and Drug Administration of the province, it can resume production.

Recently, the State Drug Administration organized a flight inspection of Changsha Jingtong Medical Devices Co., Ltd. During the inspection, it was found that the company's quality management system mainly had the following defects:

(1) The technical requirements of the company's “Custom Fixed Denture” product require that the surface roughness Ra is less than or equal to 0.025μm, but the enterprise does not have a roughness analyzer and does not comply with the “Medical Device Manufacturing Quality Management Specification” and related “Appendix” (hereinafter referred to as “Appendix”). The "specification" of the "information" shall be accompanied by the requirements of the inspection sites and facilities that are compatible with the production scale, variety, and inspection requirements of the product.

(II) Oxygen cylinders used for casting in enterprises, liquefied gas cylinders placed in oxygen chambers, no exhaust ventilation facilities, and separated from the casting chamber and pure titanium casting chamber by glass only, not compliant with the “Standard” inflammable, explosive, toxic, The hazardous materials should be stored in a special area, with obvious identification and special personnel's requirements for safekeeping and distribution.

The “Embedded Operation Instructions” (No. CSJT/SOP-04) of the company stipulates that wax embedding should be placed on a vibrator to prevent inner-column air bubbles, but the company does not have an oscillator, and the company does not comply with the “Regulations”. Equipped with the production equipment and the scale of production equipment, process equipment, etc., and ensure the effective operation of the requirements.

Steel plate electrolytic polishing process carried out in the production area of ​​the company's plastic tray steel support group, the voltage is set to 16.2V, but the specification of the “Operation and Maintenance of Electrolysis Machines” (No. CSJT/SB-15) specifies the voltage is set to 12V, and the casting operation guide The book (document number CSJT/SOP-05) stipulates that the casting ring is placed in a 930-950°C oven for baking, with a baking time of 40-45 minutes, but in the "Stent (Cobalt-chromium) Embedding Material Instructions for Use" The prescribed temperature rise to 950°C and heat preservation for 45-60 minutes will not allow the company to identify and keep records of design and development changes. If necessary, the design and development changes shall be reviewed, verified and confirmed, and Approved before implementation.

(1) The registration number of the stent alloy used in the company's main material record on May 5, 2018 was Suzhe Yaoxuan (Jun) Word 2013 No. 2631287, but the actual use of the cobalt-chromium alloy registration certificate number was China National Machinery Corporation entered 20172631496. The batch number and validity period information of the stent alloy used on May 5, 2018 were not recorded in the main material records. The procurement records that did not meet the requirements in the “Specifications” should meet the traceability requirements.

(2) Check the raw records of the raw materials for cobalt chrome alloy SPARTALLOY ALLOY that have batch numbers of 4962 and 4436, and the inspection dates are March 30, 2018 and March 19, 2018, respectively. , Enterprises that are not in compliance with the "Code" shall conduct inspection or verification of purchased items to ensure that they meet the requirements of production.

After the resin tooth products in the company's raw material warehouse are unpacked, they are mixed in one drawer in multiple batches. It is difficult to distinguish the batch numbers of resin teeth produced in different batches. It does not comply with the traceability procedures that enterprises should establish in the “Specifications”, and specifies the product traceability range. , degree, identification and necessary record requirements.

The company did not provide the certification of the medical institution qualifications of dental model number 2018P0583, dental model number 2018D05134, dental model number 2018A05165, and it does not meet the requirements of the “specification” to select a medical institution with legal qualifications, and save the medical organization qualification certificate. And establish file requirements.

The company did not provide the “Annual Summary Report of Medical Device Adverse Events” in the previous year. Enterprises that are not in compliance with the “Regulations” should establish monitoring systems for adverse events in medical devices in accordance with the requirements of relevant laws and regulations, carry out monitoring and re-evaluation of adverse events, and maintain relevant Record requirements.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the company does not comply with the relevant provisions of the medical device production quality management standard. The production quality management system has serious defects, and the State Drug Administration has ordered Changsha Jingtong Medical Instrument Co., Ltd. According to the law, the company was ordered to immediately suspend production and rectification, and to deal with violations of the "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 680) and related laws and regulations. The Hunan Food and Drug Administration was also required to require the company to evaluate product safety. Risks, which may cause potential safety hazards, should be recalled in accordance with the "Administrative Measures for Medical Device Recall" (Order No. 29 of the State Food and Drug Administration).

After the company completes the rectification of all the projects and is followed by the local Food and Drug Administration of the province, it can resume production.

Recently, the State Drug Administration organized a flight inspection of Hainan Taihe Medical Technology Co., Ltd. During the inspection, it was found that the company's quality management system mainly had the following defects:

The enterprise manager's representative is the reviewer of the product inspection report. It has not been trained in accordance with the requirements of his position and does not meet the requirements of the "Medical Device Manufacturing Quality Management Specification" and related "Appendix" (hereinafter referred to as "the Code"). product quality Personnel working should be trained in accordance with the requirements of their posts, with relevant theoretical knowledge and practical operating skills.

The company's medical device production area shares a logistics corridor with another food production area. It does not comply with the production requirements of the factories and facilities in the “Regulations.” The overall layout of production, administrative and auxiliary areas should be reasonable and must not interfere with each other.

The site found that the host product of the enterprise product had no purchase record, and the supplier file in the probe line, remote control line, etc. lacked the qualification certification documents. The procurement records should not be established in accordance with the “Regulations”, including the procurement contract, raw material list, and supplier qualifications. Proof documentation, quality standards, inspection reports, acceptance criteria, etc. Purchase records should meet traceability requirements.

(1) There is no corresponding batch production record for the production behavior reflected in the work load record (from April to May of 2018) of the company's production process 2, and each batch (table) product that does not comply with the "Code" should be There are production records and meet the requirements of traceability.

(II) The factory product inspection report (lot No. 170329 No. 170329-001) of the company's products is inconsistent with the inspection procedures for the products at the factory, and lacks the inspection items of 'Working Situation Inspection' 5.1 in the inspection procedures. Compulsory standards and technical requirements of registered or filed products shall establish inspection procedures for the products and issue corresponding inspection reports or certificates.

The company failed to provide a record of the corresponding disposal measures for the WSJ-B type of rotary magnetic diabetes treatment instrument failed product (batch number 150330). If the company does not comply with the “Regulations”, the company shall identify, record, isolate, and review the non-conforming product. According to the result of the review, the requirements for the corresponding disposal measures shall be taken for the nonconforming product.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the company does not meet the relevant regulations for the quality management of medical devices, and there are serious defects in the production quality management system. drug The Supervising Authority has ordered Hainan Taihe Medical Technology Co., Ltd. to order the company to suspend production and rectification immediately.medical instruments The Regulations on the Supervision and Administration (State Council Decree No. 680) and related laws and regulations shall be dealt with in accordance with law. At the same time, the Food and Drug Administration of Hainan Province shall be required to enterprise Assess product safety risks, and may cause potential safety hazards, should recall related products in accordance with the "Measurement of Medical Device Recall Management" (Order No. 29 of the State Food and Drug Administration).

After the company completes the rectification of all the projects and is followed by the local Food and Drug Administration of the province, it can resume production.