Medical network - February 16 national food administration of drug safety inspection 10 drug, suspected of a serious illegal operation, serious violation, not drug GSP, six GSP certificate has been revoked, four rectification within a time limit.
On February 14, administration issued "about source pharmaceutical co., LTD in fujian and so on 10 pharmaceutical wholesale enterprises results announcement 24 (2017). Administration on 10 pharmaceutical wholesale enterprises fly after inspection, every company is different degree has a problem.
▍ provides cie, fictitious flow, goods inconsistent, 6 drug was removed from the GSP
Source in fujian pharmaceutical co., LTD., call for others to provide private deposit official seal and legal person power of attorney issued false suspicion of serious illegal operation, the GSP certificate has been revoked, after being examine these conditions, in accordance with the law seriously, until the revocation of the pharmaceutical trade license, and shall be investigated for the responsibility of the enterprise's legal representative. The administration says it will oversee the case.
Jewim lida medical logistics co., LTD., Beijing huitong pharmaceutical co., LTD., nanjing bank of Beijing the four seasons of pharmaceutical co., LTD., zhejiang lang pharmaceutical co., LTD., fujian southeast pharmaceutical co., LTD., five drug alleged tampering with temperature and humidity monitoring system data, some drug sales ticket goods inconsistent, fictional drug sales flow, buying and selling stock record is not true, the power of attorney for forgery, suspected of a serious breach of drug GSP, GSP certificate has been revoked, the administration of the requirements in accordance with law, investigate and punish the illegal management behavior.
▍ 4 druggist rectification within a time limit
Another good abundant pharmaceutical trading (Shanghai) co., LTD., Shanghai leading pharmaceutical co., LTD., jiangsu warburg pharmaceutical co., LTD., hangzhou xiaoshan pharmaceutical co., LTD, there is no internal audit results analysis and judgement standard of content material change is not the organization to carry out the special audit, increase the office area after the alteration formalities, not according to requirements to carry out the special audit, temperature alarm limit setting error does not comply with the provisions of the drug GSP problem was ordered to make correction.
▍ the deployment of the state council, administration requires high pressure continuously flow check
Fly 10 companies, each has a problem, the situation in the administration and the provinces of flying inspection announcement, nothing new. Administration way around is to require for this is that the agency, continue to strengthen the supervision and inspection of pharmaceutical circulation enterprises, increase the pertinence and effectiveness of, continue to keep high pressure situation, investigated the illegal management behavior.
Current examination from 2016 to now, in fact, there has been no slacken, and issued by the state council on February 9, "on further reform and improve the pharmaceutical production circulation use policy several opinions, on the medicine circulation field problems also clear requirements: business administration, public security departments to jointly carry out special inspection regularly, to crack down on loan business licenses, false trading, falsified records, illegal channels selling drugs, commercial bribery, fraud, price monopoly price and violation behavior, such as forging, falsely making out invoice.
Under the deployment of the state council, the circulation of fly high pressure will be continued.
Attachment: administration about source pharmaceutical co., LTD in fujian 10 pharmaceutical wholesale enterprises, such as test result announcement (24, 2017)
According to the administration of state food and drug supervision and administration of pharmaceutical circulation field on the regulation of illegal conduct announcement "(no. 94, 2016, hereinafter referred to as the" notice "), recently, the state food and drug supervision and management of the administration organization to flight check of 10 pharmaceutical wholesale enterprises, will check the result notice is as follows:
A, on-site inspection, found that fujian source in pharmaceutical co., LTD., suspected of a serious illegal operation, specific situation is:
The companies suspected of illegal run drugs provide conditions for others, corporate office with three other company seal, huang attendants of the enterprise employees, and the enterprise to the medical institutions issued to huang false legal person accredit a power of attorney. Enterprise part of drug storage area was not equipped with automatic detection of temperature and humidity of the equipment. In multiple monitoring data is incomplete.
Announcement of the enterprise is the first listed: illegal drugs provide conditions, for others sales record is not true, cargo accounts do not agree fare such as illegal business behavior, suspected of a serious breach of the pharmaceutical administration law of the People's Republic of China and the drug supply quality management norms "(hereinafter referred to as the drug GSP) and other relevant provisions. Administration of state food and drug supervision and administration of fujian province food and drug administration immediately revoked the aforesaid enterprises "drug-handling quality management standard certificate", and the illegal conduct a case for investigation. After being related cases verify, in strict accordance with the "notice" requirements, in accordance with the law seriously, until the revocation of the pharmaceutical trade license, and shall be investigated for the responsibility of the enterprise's legal representative. The above cases suspected of serious illegal operation, the state food and drug administration supervision will be supervised and requirement of fujian province food and drug administration, increase the intensity of case investigation, ensure that investigated in place.
Second, on-site inspection, found that Beijing jing wei lida medical logistics co., LTD., and other five the management behavior of pharmaceutical wholesale enterprises suspected of a serious breach of drug GSP, specific situation is:
(a) Beijing jing wei lida medical logistics co., LTD., suspected tampering with temperature and humidity monitoring system of data, the normal temperature, cool and used by the library of "Beijing kalumpang technology development co., LTD." log shows that there are multiple temperature and humidity monitoring system of the modified data record, use of constant technology co., LTD. Of the "Beijing industry in incubator temperature and humidity monitoring system with internal platform, and can be tampered with the temperature data of incubator. Companies to replace the cold storage temperature and humidity monitoring system and the probe not the organization to carry out the special audit. Enterprise for cold-chain drugs when receiving, failure to check transit on-board monitoring probe temperature record; Foreign entrust the transport chain drug, refrigerated truck to the shipper of temperature monitoring probe data not according to specification for review.
(2) of Beijing the four seasons huitong pharmaceutical co., LTD., part of the drug sales ticket account goods, computer system shows its some enterprise purchases from hubei drug sales to a Beijing hospital, but the site does not provide the above hubei some enterprises with cargo counterparts issued orders, invoices and enterprise to the Beijing hospital of the invoice. The temperature and humidity automatic monitoring system function recognized by the enterprise in the part of the validation report, enterprise quality director ji in more than one report records shall be signed by the quality assurance manager confirmed not the manually signed. Enterprises formulated the corresponding drug purchase returned to the operation procedures. Seal management is not standard, blank with printed "special seal for outbound goods peer list.
Enterprise organization chart with the list of institutions. For part of the first battalion enterprise registered with single cargo counterparts appeared inconsistent style did not collect. Enterprise equipped with temperature and humidity monitoring equipment cannot effectively monitoring, regulation of drug storage. After the temperature and humidity monitoring terminal malfunction of enterprises did not carry out repairs and take emergency measures to cause data loss. The enterprise part temperature and humidity monitoring terminal overrun the historical data and historical monitoring data inconsistency within the same period, suspected of the data is not real. A warehouse store has to cool and room temperature preservation, but its temperature and humidity monitoring probe to dismantle or with heat insulation material. Chinese medicine yinpian enterprise of the rolls for clindamycin phosphate for injection, hydroxy benzene sulfonic acid calcium tablets and so on dozens of Chinese medicine yinpian drugs. Companies such as drugs and disinfection disinfection products non-drug readjusting.
(3) of nanjing silver of pharmaceutical co., LTD., suspected of drug sales to fiction, extraction of the enterprise sales list and computer sales record and on-spot inspection, found that its sales to nanjing some clinics 239 batches, the total amount is 35143 yuan sales record is fiction. The enterprise beyond biological products "al living bacterium bacillus subtilis 2 particles", part of the quality management in a computer system based data is not associated with operating effectively, failed to correspond to supply unit business scope. The enterprise loss of temperature and humidity historical data.
(4) zhejiang lang pharmaceutical co., LTD. Drug sales record is not true, drug pin back recycling goods, acceptance, sales records do not agree with the actual date again. Computer sales system shows that the enterprises exist many pens from Beijing pharmaceutical companies to return the goods acceptance, but has failed to provide the relevant certificates and documents. Temperature and humidity monitoring equipment numerical is significantly lower than the actual values; Temperature and humidity monitoring agent point number, the system parameters such as time, alarm, upper and lower limits can be set directly by manual operation, and the risk of tampering with data; Temperature and humidity monitoring system for SMS alarm connection fails. Enterprise according to the requirements of the temperature of the packaging label stored drugs, a cool library part monitoring agent point records show that the phenomenon of has continued to exceed bid, record to exceed bid more than 3 ℃.
(5) pharmaceutical co., LTD., fujian southeast financial vouchers according to huang to this enterprise transfers BuChaKuan, the enterprise provides the huang of henan accredit a power of attorney of the company for forgery. When the enterprises return drug issue a number of negative tax invoices content is not real, positive and negative output invoices do not match the buyer and the goods name. The enterprise receiving staff not to verify the outbound order seal of suppliers, part of the outbound order seals do not agree with first battalion, the examination and approval materials. This enterprise is unable to provide part of the cold chain drug transit temperature data. Temperature and humidity monitoring system in a number of data records with the background data backup, suspected of fraud is temperature and humidity data.
Administration of state food and drug supervision and administration of relevant provincial food and drug administration revoked the enterprise certificate, the drug supply quality management standard certification in accordance with law, investigate and punish the illegal management behavior, and supervise the enterprise earnestly rectification in place.
Three, on-site inspection, found that li & fung pharmaceutical trading (Shanghai) co., LTD., and other four problems does not comply with the provisions of the drug GSP pharmaceutical wholesale enterprises, the specific situation is:
(a) li & fung pharmaceutical trading (Shanghai) co., LTD. Internal audit in the quality management system documents formulated the contents of the analysis and the result judgement standard, etc. The company did not equipped with automatic monitoring system to meet the requirements of drug GSP temperature and humidity host, UPS power supply can't effective realization of automatic monitoring system for temperature and humidity uninterrupted the normal operation of the power supply, low safety monitoring data backup. Not according to requirements of the enterprise operation and management of data in a computer system in accordance with daily backup.
Shanghai leading pharmaceutical co., LTD. (2) quality management system as the key elements of major changes in the organization carries out the special audit. This enterprise inspector zhao mou part-time warehouse head at the same time. Incubator and cool storage agent did not implement in accordance with the requirements before use. Computer system on downstream purchase medicine unit enterprise type and scope of production and business operation not valid identification. Computer system operation and management of data is not required for daily backup. The enterprise library at room temperature automatic monitoring system of temperature and humidity lower limit temperature Settings below requirements. Companies to return was not strict implementation of computer system management, and part of the returned to the drug store in the delivery area.
(3) the warburg pharmaceutical co., LTD., jiangsu province in the original registered address increase the office area after the alteration formalities, not according to requirements to carry out the special internal audit. This enterprise for multiple business units and their related personnel responsibilities and authorities, such as not to be specified. The enterprise part of the first battalion enterprise information provided is incomplete. 1 very cold, very hot refrigerator report validation content is not complete. Part of the temperature and humidity monitoring data is missing.
Hangzhou xiaoshan pharmaceutical co., LTD. (4) a cool library and cold storage temperature alarm limit setting error, cold storage, a cool library history of temperature and humidity data are overweight. Refrigerator temperature and humidity monitoring is not in accordance with the validation of fixed position. Back after the business to sell drugs did not put in storage according to the requirement, and can't provide relevant data to return before the drug temperature control.
Administration of state food and drug supervision and management of the relevant provincial food and drug administration shall be ordered to rectification within a time limit, the enterprises and supervise the enterprise earnestly rectification in place.
Four, total bureau of national food and drug supervision and administration of the provinces, autonomous regions and municipalities directly under the food and drug administration will continue to strengthen the supervision and inspection of pharmaceutical circulation enterprises, to increase the pertinence and effectiveness of, continue to keep high pressure situation, investigated the illegal management behavior. To investigate does not reach the designated position, the rectification is not in place of the enterprise, are not allowed to authentication, may restore operation.
Please take note.
The food and drug supervision bureau
On February 10, 2017 |
