The clean reporting center will be opened

for drug manufacturing and quality illegal activities

To activate public interest reporting after the Binex incident, operated anonymously from the 1st

The MFDS opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in order to revitalize public interest reporting after Binex drug manufacturing incident.

 

The center operates anonymously to increase the reporting rate.

 

The MFDS announced on the 1st that it has opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in the representative website.

 

The report center was opened by the MFDS to prevent recurrence when the fact of the voluntary manufacture of drugs was discovered at the Binex Busan Plant.

 

In order to promote public interest reporting, it will be operated completely anonymously.

 

The report center is established on the website of the MFDS and can be reported by phone [phone]) or e-mail ([e-mail]).

 

In an official letter sent to each pharmaceutical organization, the MFDS said, "We have opened the Clean Report Center for Drug Manufacturing and Quality Unlawful Behavior to promote public interest reporting and raise awareness of intentional and illegal serious violations in relation to pharmaceutical GMP manufacturing establishments." The MFDS ordered, "Please publicize it so that all citizens can easily access and report intentional and illegal activities." Previously, the MFDS confirmed violations of the Pharmaceutical Affairs Act such as ▲Use of additives at will without permission to change ▲Double-write manufacturing records falsely ▲Without changing the manufacturing method ▲Randomly changing the amount of raw materials, etc.

 

through administrative investigations on Binex and Vivozon.

 

In the case of the two companies, especially in preparation for inspection by the MFDS, all processes from raw material weighing to completion of manufacturing were falsely written using a manufacturing record in the same format as the licensed matter, and the records used in actual manufacturing were found to have been discarded after manufacture.

 

In addition, the MFDS uncovered the failure to conduct tests on finished products and raw materials at one site through additional inspections at 30 entrusted and entrusted manufacturing sites nationwide, and some of the product standards were not prepared.

 

The MFDS plans to establish a special planning and inspection team for GMP to prevent recurrence of any manufacturing activity.

 

This is the expansion of regular GMP surveys conducted every three years.

 

It plans to operate a reporting center to activate public interest reporting, and cancel the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and creating false and double records.