Vivozon Pharmaceuticals said that it has received a final administrative disposition from the Ministry of Food and Drug Safety for 26 drug manufacturing violations.

Vivozon has received a final disposition notice from the Ministry of Food and Drug Safety for making drugs illegally.
Vivozon has received a final disposition notice from the Ministry of Food and Drug Safety for making drugs illegally.

The regulatory disposition comes after the ministry suspended the making and selling of products made by Vivozon and ordered their recalls for producing them in different processes from approved ones in March last year.

The violation includes seven cases of using unauthorized additives to make medicines, one case of conducting unauthorized tests, and 18 cases of not conducting safety tests.

The ministry ordered a four-month suspension for products that used unauthorized additives and failed to undergo safety tests and one month for products that did not undergo safety tests.

The regulator also suspended tablet production at the plant for one month and 29 days, capsule for one month and 14 days, syrup for one month and seven days, and cream for 15 days.

Vivozon said it has identified items that have added unauthorized additives other than the main ingredient or changed the manufacturing method and either withdrawn their permit or transferred them to a contract manufacturing organization (CMO).

In addition, the company is planning to re-implement a process validation (PV).

For the item that conducted unauthorized tests, the company has officially received approval for the test method as it was a more efficient way of testing.

The company is also re-conducting the safety test for drugs that have not undergone safety tests or are missing such data.

“As the non-compliant part was due to differences in excipient control or manufacturing method, we would like to reemphasize that there are no problems with the efficacy or safety of our products,” a company official said. “We will quickly carry out follow-up actions according to the administrative disposition and focus on management at the group level to prevent a reoccurrence of permission violations.”

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