Servier Korea received a warning from the Ministry of Food and Drug Safety after failing to comply with the management standard for imported medicines.

According to the ministry, consumers filed complaints to the Korean unit of the French drugmaker that some of Vastinan MR Tab. (trimetazidine hydrochloride), an angina treatment, were found to have broken in press-through packages before opening.

However, the company did not prepare measures to prevent a similar mishap which violated the domestic management standard for drug imports, the ministry said.

A pharmaceutical importer must create a document for each product to manage each product’s quality and the criteria for product management.

The quality control standard contains reams of information, such as the product name, manufacturing number or management number, period of use, test order number, test items and standards, measures to prevent contamination during sample collection, and management of stored samples.

The product management criteria include warehousing management, handling of faulty products, and the release and return of products.

Not only Servier Korea but E&G Aestech and Pharmapia received the government’s warning after failing to comply with the management standard for imported drugs.

E&A Aestech did not store a sample of Lipoaran Inj. (thioctic acid), and Pharmapia did not store a sample of valsartan.

lhs@docdocdoc.co.kr

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