A wave of medical devices flying in the medical apparatus on May 5th swept through. 

 

In 2017, the state administration of drug administration has launched two batches of tests involving 16 medical equipment manufacturers. 

 

Beyond that, the local drug administration has moved on. So far, anhui two provinces and cities have several machinery enterprise, Shanghai fly was found problems in the inspection, the seizure of production, improvement, and even, the investigation of the punishment. 

 

Anhui province: one armed company was seized and two deadlines changed 

 

On March 31, anhui province's drug inspection team suddenly inspected anhui hongji weiwei medical equipment development co., LTD., according to the anhui provincial drug administration. 

 

Fly the group found that the enterprise of natural latex condoms registration has expired on September 3, 2016, but enterprise is still in the dark hidden passion in the workshop production and packaging. A total of 441 barrels of unwrapped condoms (about 10, 000 per barrel) were tallied at the site by law enforcement officials. 

 

Anhui province food and drug administration to fly the group of 441 barrels of unpacked condoms and the seizure of production and processing equipment, and ordered taihe county food safety case for investigation of the enterprise, instruct fuyang city oversee food and drug administration, and the results are notified of the enterprise product registration department. 

 

The flight check, also found that the kang YaoXie co., LTD in anhui, such as incomplete materials procurement production records, inspection equipment and reagents cannot meet the demand, raw material and supplier not classified management, and other 9 defects. Anhui fills the biological engineering co., LTD., is analysis of days equal inspection record is not complete, the production of the instrument is optional alter, part of the raw material coding management but did not set up a corresponding control program such as seven defects. 

 

The two manufacturers were immediately ordered to rectify the problem by the flying inspection team. 

 

Shanghai: six armed companies have suspended production, two of which have been filed 

 

The bureau has conducted a flight inspection of some medical device manufacturers, according to the Shanghai drug administration. 

 

On-site inspection, found that there are four machinery enterprise does not conform to the stipulations of the YiXie GMP related behavior, production quality management system, there are serious defects of Shanghai food and drug administration to instruct enterprises to suspend production for rectification, and evaluate the product security risks, could lead to potential safety problems, in accordance with the provisions of the measures for the management of medical device recall recall related products. 

 

The four medical device manufacturing enterprise includes: Shanghai silicon lai medical instrument co., LTD., Shanghai expo photoelectric instrument co., LTD., Shanghai plant health materials co., LTD., Shanghai feng hui medical technology co., LTD. 

 

Among them, the silicon medical instrument co., LTD. And Shanghai expo Shanghai photoelectric instrument co., LTD has also been found in the inspection, there are suspected of violating the regulations on the supervision and administration of medical devices and related rules of behavior, district by the enterprise market supervision bureau investigation, handling in accordance with the law. 

 

Xiao bo technology development co., LTD. In addition, Shanghai is also does not conform to the stipulations of the YiXie GMP behavior, enterprise of the medical device manufacturing enterprise license has expired. The Shanghai drug administration requires that companies not engage in medical device production until they have regained their production licenses. 

 

Shanghai oliang medical equipment co., LTD. Was found to be in discontinued production during a flight test. Shanghai municipal food and drug administration requirements, before resuming production enterprise shall, in accordance with the "measures for the supervision and administration of production of medical equipment rules written reports of area market regulator, the inspection qualified rear can resume production. 

 

Here are the details of their respective questions: 

 

1, Shanghai silicon medical instrument co., LTD mainly exist the following defects: main components (transformers, oil free air compressor) and registration certificate of product configuration and main components of the information is not consistent, but the company did not deal with change to register, also did not provide related validation data; Portable dental unit in the product registration certificate for teeth cleaning machine, light curing machine should have effective medical device registration certificate, oil-free air compressor should be effective the first kind of medical device registration certificate/certificate, but the enterprise is unable to provide oil-free air compressor medical device registration certificate/certificate, teeth cleaning machine, light curing machine products in the warehouse without Chinese label; No supplier in the purchase contract of the medical oil-free air compressor shall be signed and sealed by the supplier, and the purchasing information of the non-oil free air compressor shall not be specified. Failing to identify the non-conforming products in the warehouse area; Failing to find the purchase invoice for the transformer (inspection date: 2017.1.9 and 2017.2.17) There is process inspection in the production flow chart of the dental treatment machine, but the enterprise fails to provide the inspection procedure for the procedure; The company does not track A material in accordance with the rules of the identification and traceable control procedures; The company fails to provide the goods and procedure inspection records according to the requirements of the inspection procedures; The enterprise does not provide a product release procedure; The enterprise does not provide filter pressure valve and other non-conforming material processing records according to the rules of the non-conforming product control procedure. 

 

2, Shanghai expo photoelectric instrument co., LTD mainly exist the following defects: major parts of the slit lamp microscope (rocker switch) manufacturers do not agree with registration certificate qualified, and enterprise fails to provide the new supplier audit records, did not sign the quality agreement, also cannot provide procurement records; Part of the debug inspection record list with test data but no product number and inspector's signature and date; The inspection report from the factory inspection report of partial unexamined data shall be "qualified" and shall cover the seal of the main inspection and approval personnel. The inspection results in the factory inspection report shall summarize the unsigned and the date of the inspection. Failing to provide training records for new recruits and key production personnel; To place water cups, food and other personal items on the platform; The inspection room is covered by a large area of peeling and water stains on the wall of the window. Parts and parts are not identified, and the number of parts are not identical. 

 

3, Shanghai health factory co., LTD mainly exist the following defects: implementation of the audit of the scene production enterprises as a trustee related audit table and audit table content by the entrusted enterprise to choose; The wall of the raw materials warehouse is mottled, and the ground water has spread to the floor under the mat of medicinal materials. The finished goods warehouse has no temperature and humidity control facilities, unable to ensure the storage condition meets the requirements of the product specification. The elastic band of returnable products in the finished goods warehouse is stored in the qualified area; Not to see the sealing machine for internal packing; The uv disinfection lamp cannot be opened in the clean zone; The identification of fully automatic disinfectant machine equipment that is still in the equipment verification stage in the sterilized cotton ball workshop is in good condition and operation. In the production workshop of the cotton production plant, the controlled documents of the controlled documents, which have been made obsolete, shall be checked. The company does not regularly review the suppliers of raw materials for disinfecting cotton balls; The quality agreement does not specify the clean grade and the initial contamination requirement of the medical gauze. 

 

4, Shanghai feng hui medical technology co., LTD., mainly exist the following defects: shipping department to check see production in vitro diagnostic reagents in March 2017 the finished product, but the company did not provide a 2017 purification workshop, electronic balance, filling machine equipment use record and disinfectant compound; The sink is rusted, the drain pipe is straight line, no anti-pouring device; The expired calcium (Ca) test kits in the production library are not in the defective area, and the number of shelves in the library is not consistent with the cargo hold. The return zone shall find no record of the total English standard. The return product is placed in the dealer's library, and there is no record of the shipper card; Failing to carry out water equipment maintenance and maintenance in accordance with regulations; The device has no status symbol; The enterprise fails to provide verification report on the time limit for internal packaging within the clean room. There is a large amount of internal packaging without any identification, and the date of cleaning and cleaning is not marked. The "standard liquid of adenosine deaminase reagent" in the laboratory standard refrigerator, and the ADA quality control (low) have expired. 

 

5, Shanghai Xiao bo technology development co., LTD mainly exist the following defects: strains no temperature record freezer, fridge freezer, short of bacterial species - 20 ℃ storage requirements; The sealing parameters of the sealing machine in the internal packaging of the enterprise have been changed, and the company has not confirmed the range of the sealing temperature and the speed parameters. The sealing strength confirms that the data is not the original measuring instrument number and the original data record, the confirmation is not sufficient; The physical and chemical testing of partial specifications of granulated products exceeds the testing standards and the result is still "qualified". Raw materials such as chloroform, methanol label should be stored in a cool, ventilated, avoid light environment, the scene is not equipped with light, ventilation, temperature and humidity control and monitoring equipment; The washed tray is placed in the area marked "unwashed"; Inside the inside packing room check the circulating box, the pruning product USES scissors to have no clean status mark; The record of the use of a chainsaw is not found on the scene; The production process requires that the working pressure of the freeze-drying machine is 110K, and there is no record of calibration of the drying machine of the drying machine. Purification workshop air conditioning system without open, differential pressure gauge shows two more the door for the negative pressure, the inner packing room, bacteria measure, positive external pressure difference between 5-10 pa; The calibration identification and calibration certificate of the water machine pressure difference table and the positive chamber bio-safety cabinet are not found. There is no sign of the invalidation of "the instruction book for the manufacture of medical induced bone matrix". The enterprise's "license for medical device production enterprise" has expired, and the enterprise may not engage in medical device production before reproducing the production license. 

 

The on-site inspection found that Shanghai oliang medical equipment co., LTD. Was in production. Before resuming production shall, in accordance with the "measures for the supervision and administration of production of medical equipment rules written reports of area market regulator, the inspection qualified rear can resume production.