CFDA: 17 companies shut down, rectification! Discovered 26 major issues

Pharmaceutical Network January 10 last year in November, the State Administration of Drug Control has issued a medical report on the Searles Medical Technology Co., Ltd. Wuhan Flight Inspection, which is issued by the General Administration of Drugs 2017 for the first flight inspection announcement.
On January 9, the General Administration of Drug Control of the People's Republic of China issued a further circular notifying the result of the fly-through inspection of 17 manufacturers.
These 17 manufacturers accepted the flight inspections organized by the General Administration of Drug Control in late November 2017 and were all in compliance with the "Quality Management Practices for Medical Device Management" compliance inspection.
The investigated enterprises throughout Hebei, Shaanxi, Chongqing, Liaoning, Henan, Guangxi, Hubei, Guangdong, Gansu, Shanghai, Anhui and other provinces.
The results of the flight test showed that among the 17 manufacturers, there were four serious problems in the operation of the quality management system. They were ordered to stop the rectification immediately and 13 of them should be rectified within a time limit.
The following is a summary of the results and the specific fly test:
17 companies were flying test results
1, Qinhuangdao City Rick Medical Devices Co., Ltd.
Inspection found a total of nine defects, of which two key items, seven general items.
Enterprises should be rectified within a time limit, and be tracked for review.
2, Shaanxi Yisheng Medical Devices Co., Ltd.
A total of 24 defects were found, of which 11 were key and 13 were general.
Should immediately stop the operation rectification, involving the violation of "Medical Device Supervision Regulations" and the relevant laws and regulations, should be severely dealt with according to law, and follow-up review.
3, Chongqing Baihe Medical Devices Co., Ltd.
Inspection found a total of 9 defects, of which 4 key items, 5 items in general.
Should immediately stop the operation rectification, involving the violation of "Medical Device Supervision Regulations" and the relevant laws and regulations, should be severely dealt with according to law, and follow-up review.
4, Shenyang Department of Nayuan Trading Company
Inspection found a total of 13 defects, of which 5 key items, the general items 8 items.
Should immediately stop the operation rectification, involving the violation of "Medical Device Supervision Regulations" and the relevant laws and regulations, should be severely dealt with according to law, and follow-up review.
5, Luoyang City, a beautiful life Medical Devices Co., Ltd.
A total of 29 defects were found, of which 10 were key and 19 were general.
Should immediately stop the operation rectification, involving the violation of "Medical Device Supervision Regulations" and the relevant laws and regulations, should be severely dealt with according to law, and follow-up review.
6, Liuzhou Ruikang Medical Devices Co., Ltd.
Inspection found a total of 18 defects, of which 5 key items, 13 items in general.
Should be rectified within a time limit, and follow-up review.
7, Hubei realistic medical equipment Co., Ltd.
Inspection found a total of 13 defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
8, Hubei Fu-kun Medical Devices Trade Co., Ltd.
Inspection found a total of nine defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
9, Henan Tiger Medical Devices Co., Ltd.
Inspection found a total of 18 defects, of which 8 key items, 10 items in general.
Should be rectified within a time limit, and follow-up review.
10, Hebei Famous Medical Devices Co., Ltd.
Inspection found a total of 12 defects, of which 4 key items, 8 items in general.
Should be rectified within a time limit, and follow-up review.
11, Guangzhou Jia source of medical reagents Ltd.
Inspection found a total of five defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
12, Guangxi Zhongsen medicine Group Co., Ltd.
Inspection found a total of 12 defects, of which 3 key items, 9 items in general.
Should be rectified within a time limit, and follow-up review.
13, Kang Medical Devices Co., Ltd. Gansu
Inspection found a total of four defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
14, Gansu Bai Xinke Industry and Trade Co., Ltd.
Inspection found a total of three defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
15, Philippine Sheng Kangchuang (Shanghai) Medical Devices Co., Ltd.
Inspection found a total of four defects, all of the general defects.
Should be rectified within a time limit, and follow-up review.
16, Dalian JMS Medical Devices Co., Ltd.
Inspection found a total of five defects, of which one key item, the general item 4 items.
Should be rectified within a time limit, and follow-up review.
17, Anhui Bao Jian to medical equipment trade limited liability company
Inspection found a total of 8 defects, of which 4 key items, 4 items in general.
Should be rectified within a time limit, and follow-up review.
26 major issues summary
According to the flight inspection report, 17 operators were identified a variety of issues, covering all parties .Section Blue and white instruments combed the following, in which there are more problems are:
1, business training programs, training content, training records, training and examination and other related information, no, or incomplete.
2, quality management personnel are not on duty, or academic / professional title is not enough, without the appropriate training, including the quality management staff of a contract has expired.
3, no sales staff settings, or after-sales service personnel without professional training.Among them, after-sales staff training record fraud.
4, did not establish employee health records, there are two companies in direct contact medical instruments The product's employee health card has expired.
5, enterprise Warehouse did not set the delivery area, return area, or the warehouse product is not placed as required.
6, the scene did not see the temperature and humidity recording instruments and other measuring instruments regularly calibrated or test records.
7. The enterprise can not provide relevant records and files for periodic inspection, cleaning and maintenance of infrastructure and related equipment.
8. The enterprise is not equipped with a computer information system that complies with the "Quality Management Practices of Medical Device Management".
9, spot checks products, companies failed to provide the supplier's sales staff power of attorney.
10. The enterprise can not provide the procurement contract or agreement with the supplier or the manufacturer, registration certificate number, quantity, unit price and other information which are not clearly defined in the purchase and sales contract / agreement.
11, the company has not agreed with the supplier quality responsibility and after-sales service responsibility.
12, the company did not make purchasing records, or purchase records incomplete.
13, companies can not provide the accompanying single with the goods; or with the goods counterparts single incomplete, such as not registered product registration number, manufacturing license number, shipping address and other content, without the receipt of the signature confirmation.
14, the company did not do acceptance records; or purchase acceptance records incomplete, non-standard.
15, medical equipment and non-medical equipment (including drug Not stored separately.
16, the company did not follow the "standard" requirements for temperature and humidity records.
17. The enterprise failed to effectively manage the expired products, failed to provide the expiration date records and did not dispose the expired medical devices.
18, the company did not establish the buyer's file, can not provide the purchase side of the medical institutions and other related qualifications license.
19, the company did not establish a sales record; or sales records provided incomplete, not required to specify the product registration number / filing voucher number, production lot number, expiration date, production license number / record voucher number.
20, the enterprise failed to effectively carry out annual self-examination of quality management, quality management system failed to cover the entire process of medical device management.
21, the person in charge of quality of the enterprise can not perform the guidance, supervision of the quality management system implementation, implementation and other due diligence.
22, the enterprise site failed to provide the first enterprise / variety audit records, measurement instruments used test records, in-house product maintenance records.
23, on-site inquiry, the person in charge of the medical equipment supervision and management of relevant laws Regulations The rules and regulations are not familiar with.
There are corporate legal person do not know in accordance with the "medical device management quality management practices" to carry out business activities; there are enterprises responsible for the quality of people do not understand the State Council on the revision of "Medical Device Supervision Regulations" decision.
24, the company did not establish a library review records, or library review records incomplete project, there is a risk.
25, no records of after-sales service, failure to carry out after-sales service.
26. Enterprises failing to carry out monitoring of adverse events of medical devices in accordance with the regulations do not have clear responsibilities of personnel.
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