The Ministry of Food and Drug Safety (MFDS) has received reports from the Ewha Mokdong Hospital about the detection of insects in infusion solutions, the agency said Tuesday.
A consequent inspection has found that Sungwon Medical (Medic-pro Corp) commissioned its manufacturing to a Philippine company, and confirmed that it violated the quality control standard, the ministry said.
It will take an administrative disciplinary step against the maker, including the operational suspension, the ministry added.
Ministry officials ordered the collection and disposal of 110,000 pieces of related infusion solutions manufactured by Sungwon Medical (License No. Jane 14-1951, model name IV-10A), and another violator, Shinchang Medical (License No. Jane 14-2083, model A110).
They also instructed the manufacturers and importers to carry out thorough quality controls. The ministry will hold a meeting with the representatives of related industries.
The officials will check the quality controls of syringe and fluid set makers and importers, too, next month.
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