Another wave of fly inspections, Jiangxi's 8 machinery enterprises were stopped production and rectification!
Another wave of fly inspections, Jiangxi Province targeting custom denture companies. After the flight inspection actually discovered a long-term unlicensed production of machinery enterprises, and another two machinery enterprises to produce non-certified zirconium dioxide all ceramic dentures.
From April 25 to April 28, 2018, Jiangxi Food and Drug Administration organized inspections of 10 custom denture companies to further promote custom dentures medical instruments Production quality management specification implementation.
In addition to the four general defects enterprise In addition to requiring rectification, another five enterprises with major defects were punished by the suspension of rectification. Three of them, including unlicensed production and production of non-registered certificate products, were initiated for investigation.
The following is issued according to the Jiangxi Food and Drug Administration:
The inspection found that the registration certificate held by Yichun Jiemei Yifang Co., Ltd. expired on November 5, 2016. The registration certificate did not include the all-ceramic tooth specification model, but the production of all-ceramic processing equipment was found in the boutique department of the company's production workshop. Taiwan, The machine has porcelain powder. There are 3 CNC machining files in the U disk inserted on it. The last modification date was April 25, 2018. At the same time, 3 cut ceramic blocks were found, 56 production dates 2017/ 04/06 empty zirconium dioxide packaging box. Found on the site a lot of used, opened or unused raw materials: lot number 1704, 1705, 1706, 1707 dental porcelain nickel-chromium alloy 8 boxes, has been used.
A number of financial vouchers and notes were found in an unopened filing cabinet in the general manager's office:
Among them, the opening time is 1 receipt receipt on November 16, 2017, and 2 processing fees in October 2017: All are marked with accounts receivable, accounts receivable, bad debt amount, rebate amount and doctor's name.
The inspection results showed that the company was suspected of long-term unlicensed production. All localities should notify the medical institutions in the jurisdiction. The dental clinic immediately suspended the products produced by the company. The Yichun City Bureau should order the company to stop production and conduct investigation.
The inspection found that the actual production address of Jiangxi Hengxin Denture Co., Ltd. (2F, No. 436, Erqi North Road, Nanchang City) and the production license stated the production address (1st floor of the transfer grain storage office of No. 288 Erqi North Road, Nanchang) Inconsistently, the enterprise registration certificate has no all-ceramic tooth specification and model, but in the period from September to December 2017, it purchased 30 blocks of zirconium, and 5 sets of zirconia burs. The company's quality management system has serious defects, and it is suspected of producing no registration certificate. Zirconia full ceramic denture, Nanchang City Bureau should order the company to suspend production and rectification, and conduct investigation.
Xinyu High-tech Innovation Dental Factory Registration Card has no all-ceramic tooth specification and model. In the production workshop, we have found a full-ceramic tooth processing machine with a milling machine (model: M600), computer, 3D scanner, crystal porcelain furnace and zirconia ceramic block and Staining fluid, The company is suspected of producing a zirconium oxide full ceramic denture without a registration certificate. The Xinyu City Bureau shall order the company to suspend production for rectification and conduct an investigation.
Examination found that Pingxiang Yingya Medical Devices Co., Ltd. non-prosthetic teeth production, sales, non-conforming product processing records, products can not be traced. No 2017-2018 annual quality management system evaluation records. Can not provide raw materials: dental porcelain alloy (batch number: 18031502 ) Inspection report. The Pingxiang Municipal Bureau shall order the company to suspend production for rectification, carry out follow-up inspections, and resume production after meeting the requirements.
The inspection found that the production license of Jiujiang Yaguan Denture Production Center stated that the production address was inconsistent with the relevant contents of product registration and production license. Jiujiang City Bureau should order the company to stop production and rectification, and urge the company to handle production changes and registration changes. Regulation It is required to revise the label of the product packaging and carry out follow-up inspection. Only after meeting the requirements can the production be resumed.
In response, the Jiangxi Food and Drug Administration requested that the enterprises involved in violations be punished strictly, through the implementation of penalties, informing medical institutions, conducting follow-up inspections, etc., to maintain a high pressure on unqualified companies, and to truly “renovate a class of products, One type of behavior'; By analogy, one by one, one by one, on the inspection of custom dentures within the jurisdiction, focusing on checking whether the actual production address is consistent with the production license, whether the actual production is consistent with the registration, and urging the company to implement the main responsibilities; strengthening information reporting, flight inspection is illegal Subsequent processing of violations shall be submitted to the Provincial Bureau before June 30th. The supervision and inspection of the denture enterprises in the jurisdiction shall supervise the relevant requirements according to the classification and classification, and submit the inspection records to the provincial bureau immediately.
In the previous March and May flight inspections, there were also serious problems in the quality management systems of three companies, and they were required to stop production for rectification.
The inspection found that: The company did not produce thermal labels produced before 2018, sales records, products can not be traced. No review of batch number 20171103 non-conforming products, no non-conforming product processing records. No production process regulations, Work instructions, etc. Training records for personnel without quality control, production management, etc. Quality manuals, appointments for management representatives not signed and issued. Non-woven backings with non-woven fabrics for raw materials, and polyethylene film coverings The supplier's quality agreement was signed. The company's quality management system has serious problems. The Yushu City Bureau should order the company to suspend production for rectification. If the company intends to resume production after the company's rectification is complete, a written application should be submitted.
Inspection found: Jiangxi Anjian Biotechnology Co., Ltd. did not meet the requirements of the production quality management standard, Nanchang Food drug The supervision authority issued a notice of discontinued production to the company on February 6, 2018. To date, the company has not passed the inspection for re-production. However, two boxes of urine monohydroxy derivative detection reagents were found in the financial office. The production lot number on the label is 180301, and the production date is 2018/03/08. In the potting workshop, 7390 pieces of phenolic derivative detection reagents were found in potted urine. No records were found on the spot; in the room next to the kitchen 2100 boxes of urine monohydroxy derivative detection reagents, ampoules, outer boxes, and outer boxes were not printed on the production lot number and production date. The urine monohydroxyl was found in the room next to the kitchen and was manually changed. Derivatives testing reagents, the changed batch number is 170705, and the existing 10 boxes, the modified batch number is 170805, and the existing 9 boxes. The coding number of the batch number found in the outer packing room is displayed as 20180301. In the packaging material warehouse, the safety bottle is found. The "position card", the number of warehouses was 35,264 (20), and on March 15, 2018, there were 6,688 libraries, and the balance was 28,576.
Penalty results: The company has serious problems in its quality management system. It is suspected of violating regulations. The Nanchang City Bureau shall order the company to suspend production and rectification, and conduct investigations. If the company intends to resume production after the enterprise rectification is completed, a written application shall be submitted. The Provincial Drug Certification Center will join Nanchang. 5. The municipal office carries out a full project inspection and it can only resume production if it meets the requirements.
Flight inspection date: March 19-23, 2018
Flying Inspection Company: Beichang Medical Technology Co., Ltd. Nanchang Electronics
The inspection found that: The company's electronic infusion pump built-in software has undergone many changes since 2014. Until June 2017, the software version number was not compiled according to the product technical requirements. It was not possible to trace back to which version of the software the national pumping failed. , Software management procedures have not yet been established. Product packaging and raw materials were found in an unnumbered room opposite the electronic building of the administrative building. There were 241 electronic infusion pump heads (lot number Y180306) and 100 change locks. The switch head of the electronic infusion pump has no status mark. After the field test, the software has been recorded, but the record of the burn process cannot be provided. There is also an electronic infusion pump pump head detection tool (home-made) ), Flow detection is in progress, no record of detection. Three boxes of unqualified products (C-type components) produced in October 2017 are found in the workshop. There are a large number of expired and unused items in the next three rooms in the third floor of the administrative building. After fittings and samples tested, no relevant records were recorded and they were not promptly disposed according to the requirements of the documents; 17 defective items of the electronic infusion pump pump head were stored in the warehouse of the raw material warehouse. According to the provisions stored in the return area.
Penalty results: The company has a serious problem with its quality management system. The Nanchang City Bureau should urge the company to stop production and rectification. If the company intends to resume production after the company's rectification is complete, it should submit a written application. The municipal office can verify the requirements before resuming production.
