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    Home > Medical News > Medical World News > The person in charge of quality was fined 100,000 yuan for forgery of license and banned for ten years

    The person in charge of quality was fined 100,000 yuan for forgery of license and banned for ten years

    • Last Update: 2021-03-29
    • Source: Internet
    • Author: User
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    On March 23, the Hunan Provincial Food and Drug Administration issued an administrative penalty decision.


    Hunan Shentaichun Pharmaceutical Co.


    On January 12, 2021, Zhou Zexian made an electronic picture of the "Drug Production License Renewal Acceptance Notice" in the Internet cafe and printed a paper copy and gave it to Xiao Yong, the sales manager of your company; January 15 On the same day, Zhou Ze produced two more electronic pictures of "Pharmaceutical Production License" (No.


    Penalties:

    Order your company to make corrections within seven days and give your company a warning and punishment.


    Give your company's legal representative Luo Yan a fine of 100,000 yuan.


    Impose the following administrative penalties on Zhou Ze, the original quality director of your company: 1.


    The following is the original text:

    Party: Hunan Shentaichun Pharmaceutical Co.


    Subject qualification certificate name: "Business License"

    Unified social credit code (registration number): 91430300184687504P

    Residence (Address): No.


    Legal representative: Luo Yan

    On February 1, 2021, our bureau received a clue that your company’s original "Drug Production License" (No.


    ▍After investigation, (1) Zhou Ze, the person in charge of your company's quality, forged a picture of the "Drug Production License" (No.


    Your company renewed the "Drug Production License" approved by the former Hunan Food and Drug Administration on January 21, 2016, and it is valid until January 20, 2021.


    Your company will begin to arrange preparations for the renewal of the "Drug Production License" from April 2020.


    On January 12, 2021, Zhou Zexian made an electronic picture of the "Drug Production License Renewal Acceptance Notice" in the Internet cafe and printed a paper copy and gave it to Xiao Yong, the sales manager of your company; January 15 On the same day, Zhou Ze made two more electronic pictures of "Pharmaceutical Production License" (No.


    As of the end of the investigation, your company has notified the above two salesmen by telephone to return or withdraw the copies of the above pictures and destroy them, and none of them have been used to carry out any business.


    ▍(2) Some records of your company are untrue and incomplete.


    1.


    2.
    Your company has no equipment use records for the circulating heat shrink packaging machine (equipment number Z-SC-023) and packaging heat sealing machine (equipment number Z-SC-024) in the outsourcing room of your company's oral solid preparation workshop.

    3.
    The operating record of the air conditioning purification system in the clean area of ​​the oral solid preparation workshop where your company stores intermediate products is missing the records on the 23rd, 24th, and 30th of 2021.

    The above facts are mainly proved by the following evidence:

    1.
    Copies of "Drug Production License", "Drug GMP Certificate", "Business License", and "Quality Person in Charge of Record Form" provided by your company.

    2.
    The "Production Suspension Notice", "Production Suspension Plan", "Production Quality Management Self-inspection Report", and "Notice on Removal of Zhou Ze as Quality Manager and Quality Authorized Person" provided by your company.

    3.
    The "Transfer Letter", "Notice of Order to Stop Production" and related records, instructions, and printouts of pictures from the Pharmaceutical Production Department of our bureau.

    4.
    A copy of the meeting minutes provided by your company.

    5.
    A copy of the operation record of your company's air-conditioning purification system.

    6.
    Records of on-site inspections by our bureau and investigation records of relevant personnel.

    7.
    "A comment on the picture of our company's false drug production license provided by your company

    Ming and supplementary explanations, explanations of relevant records, and explanations of the company’s sales supervisor, warehouse supervisor and business liaison Chen Weiping and Yu Qiang

    8.
    Your company's theophylline sustained-release tablets (specification 0.
    1g*24 tablets, batch number 20201102)

    Sales records, shipping list, shipping records, finished product ledger, location card, sales invoice, copy of subsidiary ledger; Xuesaitong tablets (specification 50mg*24 tablets, batch number 20201201) sales records, shipping records, finished product ledger, Copies of location cards, sales invoices, and detailed accounts.

    The above-mentioned actions of your company violated the second paragraph of Article 41 and the first paragraph of Article 43 of the "Drug Administration Law of the People's Republic of China" (2019 Revision), Article 19 of the "Measures for the Supervision and Administration of Drug Production" and "Drugs "Production Quality Management Regulations (Revised in 2010)" Article 4, Article 42, Article 72, Article 159, and Article 295.

    In view of your company's initiative to withdraw and destroy the forged "Pharmaceutical Production License" (No.
    : Hunan 20210028) picture paper photocopy, and did not use this forged "Drug Production License" to carry out any business, there is no illegal income, and actively Cooperating with the investigation, in accordance with Articles 122 and 126 of the "Drug Administration Law of the People's Republic of China" (Revised in 2019) and Article 27, Paragraph 1, Item 1 of the "Administrative Punishment Law of the People's Republic of China" As well as the relevant provisions of the administrative punishment procedure, the law enforcement officers of our bureau delivered the "Administrative Punishment Hearing Notice" to the parties (that is, your company and legal representative Luo Yan, and the original quality director Zhou Ze) on March 10, 2021.
    "[(Hunan) Drug Administration and Drug Administration Penalty Notice [2021] No.
    40)].
    The parties voluntarily gave up their statements, defenses, and hearings.

    Based on this, our bureau will order your company to make corrections within seven days and give your company a warning and punishment.

    Give your company's legal representative Luo Yan a fine of 100,000 yuan.

    Impose the following administrative penalties on Zhou Ze, the original quality director of your company: 1.
    Impose a fine of 100,000 yuan; 2.
    Prohibit activities such as drug production and operation for ten years.

    Please pay the fines and confiscations to the non-tax income remittance settlement account at the Treasury Office of the Hunan Provincial Department of Finance within 15 days from the date of receipt of this administrative penalty decision (Account opening bank: Industrial Bank Changsha branch Jiangbin branch, account: 368120100100249628) .
    If the fine is not paid, in accordance with Article 51 of the "Administrative Punishment Law of the People's Republic of China", this bureau will impose a daily fine of 3% of the fine amount and apply to the people's court for enforcement according to law.

    If your organization, legal representative Luo Yan, and original quality director Zhou Ze disagree with this administrative penalty decision, you can apply to the Hunan Provincial People’s Government or the State Drug Administration within 60 days from the date of receipt of this administrative penalty decision.
    Reconsideration; it is also possible to file an administrative lawsuit in the Changsha Railway Transportation Court within six months according to law.
    During the period when an administrative reconsideration is applied for or an administrative lawsuit is filed, the administrative punishment shall not be suspended.

    Hunan Provincial Drug Administration

    March 12, 2021

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