The violation rate under Good Manufacturing Practice (GMP) rules climbed from 37.9 percent in 2022 to 41.3 percent in 2023, before easing to 26.8 percent last year and 22.7 percent in the first half of 2026.
The Ministry of Food and Drug Safety compiled the figures from regular and special inspections and submitted them to Rep. Heo Jong-sik of the ruling Democratic Party. The 20 worst offenders racked up 166 violations, and five were caught 10 times or more.
One manufacturer was cited 12 times over the period, though the data did not name any companies.
"The entire system of monitoring, sanctions and follow-up for repeat violators must be overhauled," said Heo, who sits on the National Assembly's health and welfare committee.
GMP rules, which the ministry uses to guarantee drug quality, cover every stage from production and testing to packaging and shipment.
AJP Takeaways
- GMP violations were found in more than 20 percent of South Korean drug factory inspections every year from 2022 through June 2026, according to Ministry of Food and Drug Safety data released Sept. 16, 2026 by Rep. Heo Jong-sik.
- The 20 manufacturers with the most violations accounted for 166 breaches, and one company was cited 12 times.
- GMP lapses abroad have been linked to patient deaths and drug shortages, including a 2020 contamination case at Japan's Kobayashi Kako that led to a record 116-day suspension.
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