The Ministry of Food and Drug Safety (MFDS) launched a surprise pharmacist inspection into Medytox's Ochang 1 plant, which has been suspected of failing to properly carry out the sterilization work for more than a decade on May 23, the News 1 reported.
Pharmacist surveillance is an overall survey of processes, quality and facilities, and administrative actions can be imposed if violations of the Pharmacist Act are found during the investigation.
Ochang Plant 1 currently produces "Meditoxin," a wrinkle-improving botulinum toxin drug sold by Medytox.
However, the issue erupted recently when a former Medytox employee filed a public complaint with the Anti-Corruption and Civil Rights Commission (ACRC), claiming that the factory had been producing products without sterilizing them during the production process of Meditoxin.
"One researcher from the MFDS and three from the Daejeon District Food and Drug Administration have secured basic data, including data related to sterilization, at the site of the Ochang Plant 1," an MFDS official said on May 24. "We will analyze the data in the future to determine whether the violation is committed and conduct another on-site investigation if necessary."
The official added that if the violation is confirmed, administrative measures such as suspension of sales or manufacturing duties can be taken depending on the issue.
According to the report, the former Medytox official pointed out that Medytox did not implement the necessary measures to sterilize frozen dryers during the production process of Meditoxin from around 2008 until recently.
In addition, the official reported that Medytox changed the manufacturing number of Meditoxin to turn the defective product into a normal product, manipulated test data, and used the raw material manufactured at nonconforming facilities to make finished drugs.