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CMOs tense up for a full day MFDS investigation

By Lee, Tak-Sun | translator Byun Kyung A

21.03.22 16:50:01

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2 to 3 regional branch officers in a group visited and investigated a company a day for mass produced item

Stressed about possibly a minuscule issue found, the industry concerned of industry-wide investigation


Set off by the Binex incident, South Korea¡¯s Ministry of Food and Drug Safety (MFDS) has started a full investigation on pharmaceutical contract manufacturing organizations (CMOs). Although it was a day-long investigation, the companies noted it was pressuring.

According to the relevant industry sources on Mar. 22, two to three regional MFDS branch officers in a group are investigating a single CMO a day.

Compared against a regular Good Manufacturing Practice (GMP) inspection running three to four days, the special investigation was only a full day long. But all the investigated companies commented they felt the heavy pressure.

Especially because the Criminal Investiga

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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