MFDS Confirms Violations of Pharmaceutical Affairs Act by Binex and Vibozon Pharmaceutics

[Asia Economy Reporter Chunhee Lee] It has been confirmed that Binex and Vibozone Pharmaceutical violated the Pharmaceutical Affairs Act by arbitrarily manufacturing pharmaceuticals and falsifying manufacturing records.

The Ministry of Food and Drug Safety announced on the 25th that, following an administrative investigation of Binex and Vibozone Pharmaceutical, violations of the Pharmaceutical Affairs Act were identified, including ▲arbitrary use of additives without change approval ▲falsified duplicate manufacturing records ▲no change in manufacturing methods ▲arbitrary increase or decrease in raw material usage.

In particular, these companies were found to have prepared false manufacturing records using forms identical to those approved for all processes in preparation for the Ministry's inspection, and records of actual materials used in manufacturing were discarded after production.

The Ministry of Food and Drug Safety stated, due to concerns about concealment and disposal of related documents, it will promptly switch to investigation to confirm additional violations and take strict administrative actions.

Furthermore, as a result of inspecting 29 consignment companies manufacturing or commissioning pharmaceuticals with the same ingredients and formulations as the products confirmed to have violations by Binex and Vibozone Pharmaceutical, negligence in management and supervision of consignees was also identified, and administrative measures will be taken accordingly.

The Ministry conducted additional inspections on 30 nationwide consignment manufacturing sites to check for similar cases. As a result, no violations identical to those of Binex and Vibozone Pharmaceutical were found.

However, one company was found to have violated the standards for manufacturing and quality control of pharmaceuticals by failing to conduct finished product and raw material tests and partially omitting product standard documentation. Administrative actions by the Ministry of Food and Drug Safety will be taken. A Ministry official stated, "(The relevant pharmaceuticals) were manufactured according to approved specifications," and "no intentional illegal acts such as concealment or disposal of related documents were discovered."

To prevent recurrence of such intentional violations of manufacturing and quality control standards, the Ministry plans to strengthen the inspection system by ▲establishing a 'Special GMP Pharmaceutical Inspection Team' to conduct regular unannounced inspections ▲setting up and operating a 'report center' for violations ▲enhancing the effectiveness of penalties and structurally improving related approval systems for pharmaceutical manufacturing and quality control.

The Ministry of Food and Drug Safety said, "We will conduct thorough and prompt investigations into Binex and Vibozone Pharmaceutical currently under investigation, transparently disclose the results, and take necessary measures," and "we will do our best to make this an opportunity to strengthen pharmaceutical safety management by actively promoting effective system improvements such as management improvements for manufacturing methods and limiting the number of consignment bioequivalence approval items."

This content was produced with the assistance of AI translation services.