For failing to comply with the regulations, the pharmaceutical company was fined 1,000,000 yuan, and the manager of the purchasing department was banned from entering the industry for life!

With the stricter supervision of the pharmaceutical industry, cases of pharmaceutical companies being punished frequently occur
.
Recently, the Food and Drug Administration in many places reported that some pharmaceutical companies were fined for producing and selling inferior drugs, and some companies were fined millions of yuan for not complying with relevant regulations
.
On April 8, the Yunnan Provincial Food and Drug Administration announced an administrative penalty information.
A pharmaceutical company in Yunnan and its principal were fined and confiscated more than one million yuan for failing to comply with the quality management standards for drug business and failing to record the purchase and sale of drugs in accordance with the regulations.
, the manager of the purchasing department was banned from engaging in drug production and business activities for life
.
According to the penalty decision, the Yunnan Provincial Food and Drug Administration conducted several on-site inspections of the company and found that the company had three major violations
.
Including the failure to strictly control the drug procurement process, the traceability of drugs has not been achieved; the computer system has not strictly implemented quality control in accordance with the requirements of the "Good Management Practice for Drug Operations", and the purchase and sale of drugs has not established true purchase and sales records
.
Among them, the on-site inspection found that the company's computer purchase and sales records and the notes provided showed that its mycophenolate mofetil capsules and tacrolimus capsules were purchased from a company in Jiangxi, but the latter denied that it had provided them with the above-mentioned drugs
.
At the same time, in the process of purchasing Mycophenolate Mofetil Capsules and Tacrolimus Capsules, the company only made formal comments to suppliers and purchased drugs Mycophenolate Mofetil Capsules and Tacrolimus Capsules.
During the audit, the source of the drug and the authenticity of the inspection report were not strictly checked.
There were often inconsistencies between the physical batch number and the single batch number accompanying the goods, and the physical goods had mixed batch numbers
.
In addition, the company's internal quality management system is not perfect, and the purchaser uses the authority of the inspector without authorization, resulting in the computer system not playing the quality control function; and the inspector fails to report the unqualified drugs to the quality management department for processing according to GSP regulations.
The source of truth cannot be traced
.
The Yunnan Provincial Food and Drug Administration believes that the above violations prove that the company's quality management system cannot effectively carry out quality control, quality assurance and other activities, and the quality and safety of drugs sold cannot be guaranteed.

.
In this regard, a penalty of 1 million yuan was imposed, and the company was ordered to suspend business, confiscated and imposed a certain fine on the main person in charge and the person in charge of quality, and was prohibited from engaging in activities such as drug production and operation for ten years.
Fines, and lifelong bans from engaging in pharmaceutical production and business activities
.
According to the new version of the "Drug Administration Law", the fines imposed on enterprises that violate the regulations have not only been greatly increased, but also the means of personal freedom penalties have been added.
, the directly responsible person in charge and other responsible personnel are also punished, including confiscation of the income obtained during the illegal act, a fine, a certain period of time or even a lifetime ban,
etc.
Both the enterprise and the responsible person are punished, and the punishment is directly imposed on the person
.
Anyone who violates the provisions of this law and constitutes a crime shall be investigated for criminal responsibility according to law
.
It is understood that since the implementation of the new "Drug Administration Law", nearly ten pharmaceutical workers have been "banned for ten years" in just a few months, and the positions involved include the legal representative of the enterprise and the person in charge of the enterprise.
, Quality person in charge, supply and marketing manager, relevant person in charge,
etc.
It is believed that these past cases are enough to wake up the alarm for pharmaceutical companies
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.