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| The medical device enterprise refused to fly inspection group!Serious consequences... |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-24 11:15:27 Number Browse：734 |
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Medical network on August 24 - jiangxi province food and drug administration, 3 solstice 7 July 2017, the agency in the province organization carried out within the scope of medical equipment management enterprise flight inspection work, involved a total of 20 concurrently wholesale or retail enterprises.
One of them, however, has openly refused to accept flight inspections from the flight inspection team, which are rare in flight inspection reports from all over the world.
The bureau said, Jiang Xijin hetian biological technology co., LTD., inspection group enterprise as a legal person of phone calls went unanswered or hang up many times, until 9:30 enterprises personnel on the inspection group dial the phone in the past, inspection group again told the flight check rules, requiring companies to send someone to the scene before 10:02 fit check, enterprise as a legal person on the phone promised to immediately send someone within the prescribed period of time to inspect the site, until 10:07 enterprises did not send someone to the on-site inspection, inspection group again call the enterprise as a legal person, to be able to get through, but no answer, refused to accept the flight check.
Dare to give the drug surveillance team to "stand up", this enterprise is not small.Of course, the consequences are serious.
Nanchang city bureau of jiangxi province food and drug administration ordered according to the regulations on the supervision and administration of medical devices "medicine medical instrument flight check method" and other relevant provisions, the company refused to accept inspection behavior in accordance with the processing.
According to the pharmaceutical medical instrument flight check way ", enterprise refuses or escapes fly inspection, should by written record inspection group, and they shall be ordered to correct, after rectification is not correct, unable to complete the inspection work, inspection conclusion judged to be not conform to the relevant quality management specification or other related requirements.
In addition, if an enterprise refuses, avoids the inspection situation and is subject to administrative penalty for violation of the law, it shall be given a heavier punishment by the drug administration.
In other words, companies refuse to fly tests and can't really avoid flying tests. Instead, they are directly judged to be unapproved and even heavier penalties.
Fly check group come, cooperate to go up!
The following main problems were also found in the flight inspection of jiangxi province's pharmaceutical inspection bureau:
1. The act of operating the medical device without permission.
Yiyang Kang Heng medical equipment technology co., LTD, on March 15, 2017 in the medical equipment business license and the second category of medical equipment business registration certificate, on March 15, 2017 is engaged in medical equipment business activities without permission.
Jiangxi provincial pharmaceutical administration has asked to file an investigation into the illegal operation of the company and deal with it according to law.
2. The phenomenon of "shell company".
Yiyang chi Yang biological technology co., LTD., jiangxi industrial co., LTD., ganzhou city our headquarters all three companies such as medical equipment sales co., LTD., the original registered business address door shut and empty.
These enterprises will be promptly implemented by the cancellation procedure.
3. Change the operating conditions of original permit approval without authorization.
Jiangxi kone medical equipment co., LTD. Has arbitrarily changed the operation address and warehouse address;Jingdezhen shengchamp medical equipment co., LTD.The operating conditions of jiang xitian trading co., LTD. Are changing, no longer conforming to the requirements of medical GSP;The existence of jiangxizze technology co., LTD. Is a common warehouse phenomenon with other enterprises;Yingtan fangyuan pharmaceutical co., LTD. Shares cold storage with other enterprises.
4. The quality leader is not on duty.
The inspection found that the quality leader of the enterprise is not in the position to be prominent. The quality person who qualified for the approval is leaving the post, and no one is performing the quality management duties.
5. Management of medical devices with low temperature and cold chain management is not standardized.
A small number of in-vitro diagnostic reagents operating cold chain facilities cannot meet the storage and transport requirements and cannot provide relevant records.
6. Incomplete information on purchase and sale records.
Individual enterprises have not established purchase and sales records;No computer management system can be used to achieve product traceability.
The above problems are also the problems in the flight inspection of the circulation of medical devices.Other common problems include the sale of unproven, outdated and substandard medical devices, as well as illegal Internet medical devices.
Compared to production areas, medical apparatus and instruments in the field of circulation fly inspection work started late, promotion than GMP inspection, circulation enterprises common cognition to fly to check and importance, also looks less.
However, the medical GSP flying inspection is gradually expanding, and more and more local food and drug administration has already begun to circulate and inspect, and the future will be normalized.The medical operation enterprise, or mo should despise to be good!
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