Fined 18,000 yuan for producing and selling inferior drugs

On March 22, the Anhui Provincial Food and Drug Administration released a piece of information that Tianma (Anhui) Sinopharm Technology Co.

Tianma (Anhui) Sinopharm Technology Co.

Party: Tianma (Anhui) Sinopharm Technology Co.

Types of illegal acts:

Suspected of violating the provisions of paragraphs 1 and 2 of Article 49 of the "Drug Administration Law of the People's Republic of China" (2015 revision).

Facts of illegality:

On July 21, 2020, received the leadership’s approval from the Anhui Provincial Drug Administration "Letter on the Inspection Report of Substandard Drugs" (Yao Jian Zong Bian Han [2020] No.

Punishment basis: Article 49, Paragraph 1 and 2 of the "Drug Administration Law of the People's Republic of China" (2015 Revision): Article 74 of the "Drug Administration Law of the People's Republic of China" (2015 Revision).

Penalty content:

Fines; Other-confiscation of illegal gains

1.

2.

The total amount of fines and confiscated amounts to seventeen thousand seven hundred and three hundred thirty two yuan and five yuan (1,7832.

Liaoning New Century Pharmaceuticals was rectified within a time limit due to three issues including the inconsistency between the actual storage conditions of some traditional Chinese medicinal materials and the regulations.

Company Name: Liaoning New Century Pharmaceutical Co.

type of enterprise

Liaoning New Century Pharmaceutical Co.

Inspection basis: "Pharmaceutical Administration Law of the People's Republic of China", "Measures for the Supervision and Administration of Drug Production", "Pharmaceutical Manufacturing Quality Management Regulations (Revised in 2010)" and its appendices and other relevant laws and regulations, and inspect six drug production links in 2021 Supervision and inspection plan, "Special rectification plan for Chinese medicine decoction pieces", "Instruction manual for on-site inspection of drug supervision", etc.

Check content:

1.

2.

3.

4.
The legal compliance of materials;

5.
The management of the retained samples;

6.
The establishment of medicinal materials used by the enterprise.

There is a problem:

1.
The company did not include the training content of the purchasing personnel on the identification of Chinese medicinal materials and Chinese medicinal pieces into the training file;

2.
The actual storage conditions of enterprise dodder, epimedium, and astragalus samples are inconsistent with the specified storage conditions.
They should be stored at room temperature, and they should be stored in cool conditions;

3.
The company has not established a sample of the medicinal part of the Chinese medicinal material Epimedium.

Treatment measures:

Order a deadline for rectification.

Rectification situation:

The rectification has been completed.