A pharmaceutical company was fined 3 million in the batch number change!

Credit China recently disclosed an administrative penalty case.

In the end, he was punished:

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The above fines and confiscated amounts to 3002608.

Basis for punishment:

According to the provisions of Article 117, Paragraph 1, Article 124, Paragraph (6), and Article 126 of the "Drug Administration Law of the People's Republic of China" (revised in 2019).

▍Illegal facts

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▍On-site inspection also found 7 defects

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The above-mentioned non-compliance with the "Good Manufacturing Practice for Drugs" violates the provisions of Article 43, Paragraph 1 of the "Drug Administration Law of the People's Republic of China" (revised in 2019).

Used to produce honey poppy shells without a license

The editor of Dandelion found that in 2017, Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
was fined more than 10,000 yuan for producing honey poppy shells without obtaining a license.

Without approval and without obtaining the "Drug Production License", the parties produced the Chinese medicine decoction honey poppy with batch numbers C21703001, C21703002 and C21703003 on March 9, 2017, March 10, and March 11, respectively.
The shell is 140kg each, and the three batches total 420kg.

In accordance with the provisions of Article 72 of the "Drug Administration Law of the People's Republic of China" and Article 27, paragraph 1 (4) of the "Administrative Punishment Law of the People's Republic of China," the following administrative penalties are imposed on the parties: 1.
Confiscation of illegal production Chinese medicine decoction pieces honey poppy shell 420kg; 2.
A fine of twice the value of the illegally produced medicines was imposed, namely: 21420 yuan × 2=42,840 yuan (two thousand and one thousand and four hundred and fourteen yuan).

1.
Confiscation of illegal income of 768 yuan; 2.
A fine of 10,000 yuan.
The above fines and confiscated amounts totaled 10768 yuan (10,700 yuan).

Was stopped by the Drug Administration in February this year

The editor of Dandelion found through inquiry that Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
was suspended from production and sales by the Gansu Provincial Food and Drug Administration in February today because it did not comply with GMP and there was a hidden risk of quality and safety.

In the drug supervision and inspection organized by our bureau, it was found that the production of Chinese herbal medicine decoction pieces by Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
did not comply with the "Pharmaceutical Production Quality Management Regulations" (revised in 2010), and there were hidden dangers of quality and safety risks.

In accordance with the provisions of Article 99, Paragraph 3 of the "Pharmaceutical Administration Law of the People's Republic of China", our bureau has decided to suspend the production and sale of Chinese herbal medicine decoction pieces of Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
from now on.