On April 10, 2017, the bureau of medicine and drug administration of jiangxi province carried out a flight inspection on 10 medical device manufacturers on April 10 to 14, 2017. As a result, four armed companies were ordered to halt production, and six weapons companies were ordered to rectify the problem within a deadline. 

 

The report shows that the inspection is to further strengthen the supervision of medical devices, and analyze the reasons for the inspection of the inspection of medical device products. This is a combination of the flight tests for medical devices and the supervision of the inspection. In fact, this is the new requirement for the fda to inspect medical devices for 2017. 

 

It is worth noting, report that four must be shutdown corrective machinery companies there is a common problem: the nonconforming control is lax, not proper to supervise the unqualified reason to conduct a comprehensive analysis, to take corrective and preventive measures, not according to requirement of product recall. 

 

Notification requirements of the medical device manufacturing enterprise should perform a recall, for proper supervision and the unqualified products, timely notify the product management enterprise and use the unit, including warning, recall and destroy ways for processing. The product control and recall should also be done at the same time for the disqualification caused by raw materials. 

 

New measures for the management of medical device recall have been launched since May 1 this year, while the jiangxi provincial bureau notified, according to the measures already began to play a real effect, unqualified medical equipment product really, also must want to recall, but not shuffle, escape. 

 

Bulletin shows that the flight check, check the 10 production enterprises, among them, six machinery enterprise was ordered to make correction and track inspection, including: medical equipment co., LTD., jiangxi David Jiang Xidan beauty industrial co., LTD., nanchang beauty medical equipment co., LTD., jiangxi evergreen medical equipment technology co., LTD., nanchang, jiangxi medical instrument co., LTD., nanchang aibo medical equipment co., LTD. 

 

There are four because of existing production conditions change, no longer conform to the requirements of the medical device production quality management system such as serious violation behavior, was investigated according to law, and shall be ordered to shut down the rectification. 

 

The main questions of these four weapons are as follows: 

 

1, nanchang, recreation and health materials co., LTD. : the organization is not sound, the on-site inspection with enterprise management representative present fit check, the rest of the staff are not present, the production workers have a holiday, and head of the enterprise's legal representative and full-time inspector in nanchang for a long time to run sales, quality inspection minister in shenyang run sales, production technology minister resigned; Rundown, and facilities do not conform to the requirements, the factory are roof, several broken roof, wooden doors and Windows broken, in the environment of the plant and poor health status, production workshop of raw materials, intermediates and finished products on site at random; Did not carry out inspection, indoor metope have stain mildew, operation table and equipment is full of dust, no traces of the inspection work, inspection of indoor only distilled water machine, electric oven, steam sterilization pot, disk scales 1 Taiwan, found no inspection medical swabs basic size of the measuring equipment; The quality management system is not sound, and it cannot provide technical documents such as manufacturing process discipline, job instruction, inspection and test operation procedures. The product is not traceable, can not provide the product purchase, the product inspection, the batch production, the process inspection, the finished product inspection, the sale and so on the record. 

 

2, nanchang city, the east China sea medical equipment co., LTD., the company production for plant expansion reconstruction in company production, management, quality inspection personnel are quit or resign before the shutdown. On the second floor, the non-clean workshop memory is: the mask machine 3, the mask belt heat machine 1, the cutting machine 2, the sewing machine 9, the vacuum packaging machine 2, the sealing machine 3; There are a number of raw materials such as non-woven raw materials, semi-finished operating clothes, surgical orders, masks, and finished masks. The records of raw materials procurement, production, inspection, process inspection and finished inspection record are not available. Unable to provide the relevant records of the system, the product cannot be traced. Many batches of products are sterile, unable to provide product sterilization records; There is a discrepancy in the way that the batch of seven batches of products that are not qualified for the inspection are not consistent, such as the use of the operation sheet at the time of the use of the procedure: "December 2, 2015" and "20150809". The production date of the mask was identical to the surgical one, and the batch number was "20151202". Main raw materials and finished products, semi-finished products, packaging cartons, etc., and put them directly on the ground. There are more non-woven fabrics in the clean room and on the first floor below the floor. 

 

3, Jiang Xizhong jiangxi medical instrument co., LTD. : the management representative is leaving at the end of 2016, inspection personnel shall be tested and approved by the site, do not have inspection company in the production of varieties of skills. No product size inspection equipment, no positive control bacteria, medium; The inspection facilities of the inspection facilities shall be valid for the period of April 1, 2016. Some of the standard solutions were recently dated October 1, 2015. The individual purification table has not been used recently; In 2015, 2014, the production of gauze piece of 18360 and 18360, the production of bandages on March 31, 400 volumes in 2017 after the return, product to sterilization, packaging printing the latest production batch number, back to the customer; The first floor, the second floor non-woven workshop, the clean area of the gauze workshop and the non-clean interval have no buffer; Non-woven air purification system is not regular maintenance cleaning workshop on the second floor, air purification system without cooling facilities, production, oral rarely use, at high temperature with the electric fan cooling; The washing machine in the clean area on the second floor is broken, and the clean work clothes are washed in the unclean area. The water making equipment in the water shop has not been run for a long time; The batch number and the batch number of sterilization are not set separately, and a batch number shall be designated in one month. The amount of epoxy ethane is not the same as the actual quantity. In the warehouse, there is A type A medical gauze dressing which is batch no. 20170302, and the chemical indicator card is not used in the product packaging. 

 

4, nanchang triumph medical equipment co., LTD. : production in the company building the first floor (not clean) found a one-time use adhesive sterile dressing production equipment, including 9 infusion stick machines, band-aid machine, partially by the side of the equipment of production has not yet been packing disposable adhcsive sterile dressings (infusion and band-aid), product packaging and production date are shown on the certificate of approval on March 2, 2017, expiry date on March 1, 2020. After check the finished goods warehouse, found that the entities logo production date is March 2, 2017, expiry date is March 1, 2020, the disposable adhcsive sterile dressing products (7 cm * 3.5 cm, specifications and type C (iv), 5 * 20 packets * 100 boxes/a) a total of 112 pieces. The inspection personnel at the site are not familiar with the inspection operation. The quality inspection room will be renovated on March 20, 2017. The 721 spectrophotometer, which is numbered KX / 3-10, has no use and maintenance records, and the certification has been proven to be valid. No "use of sterile infant care for the final product inspection procedure". The two doors that communicate between the clean zone and the outer compartment are not completely closed. Air purifying systems and purified water systems have no record this year. The production of a sterile infant care button, which is manufactured and assembled on April 13, 2017, will not conform to the regulations of batch no. 20170302. Two are not numbered for use in epoxy ethane sterilization tank, one of which is unverified before it is opened. The epoxy ethane parsed area is made of cotton gauze material.