MFDS "Investigating Allegations of K Syringe Production at Uncertified Factory by Punglim Pharmatech"

[Image source=Yonhap News]

[Asia Economy Reporter Kim Hyemin] The Ministry of Food and Drug Safety announced on the 24th that it is investigating allegations that Punglim Pharmatech, which manufactures low dead space (LDS) syringes for COVID-19 vaccinations, produced medical devices at a factory not certified by health authorities.

The factory in question is Punglim Pharmatech's new plant located in the Saemangeum Industrial Complex in Gunsan, Jeonbuk. This facility has not yet received certification for Good Manufacturing Practice (GMP) for medical device manufacturing and quality control.

Following the allegations, the Ministry of Food and Drug Safety began inspecting Punglim Pharmatech's new plant from the afternoon of the previous day to verify whether syringes are actually being produced there.

According to the Ministry, even before GMP certification, manufacturing, prototype production, and production of export products for the purpose of verifying production facilities do not violate the Medical Device Act. However, medical devices sold domestically must be produced in GMP-certified facilities. It is known that Punglim Pharmatech is also producing quantities for export.

Meanwhile, Punglim Pharmatech is a manufacturer of LDS syringes, also known as "K syringes." LDS syringes are special syringes designed to minimize vaccine waste by having almost no space between the piston and the needle.

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