MFDS Temporarily Suspends Manufacturing and Sales of 9 Pharmaceuticals Produced by Chong Kun Dang

Jongkundang Headquarters (Provided by Jongkundang)

[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety (MFDS) has issued a provisional manufacturing and sales suspension order for nine pharmaceutical products produced by Chong Kun Dang due to violations of the Pharmaceutical Affairs Act.

On the 21st, the MFDS announced the results of a special unannounced inspection of pharmaceutical manufacturers conducted by the 'Pharmaceutical GMP Special Inspection Team' from the 5th to the present, and took such measures accordingly.

Following inspections of four companies, the MFDS imposed provisional manufacturing and sales suspension measures on nine pharmaceutical products manufactured (including contract manufacturing) by Chong Kun Dang. The MFDS explained that it confirmed violations of the Pharmaceutical Affairs Act by Chong Kun Dang, including the unauthorized use of additives without obtaining approval for changes.

In addition to Chong Kun Dang, one company was found to have violated pharmaceutical manufacturing and quality control standards, such as failing to conduct performance tests on media used for microbial limit tests, and administrative actions will be taken. The MFDS reported that no violations of the Pharmaceutical Affairs Act were found in the other two companies inspected.

The MFDS confirmed the following violations of the Pharmaceutical Affairs Act in Chong Kun Dang based on the special inspection results: ▲unauthorized use of additives without approval for changes ▲falsification and duplicate preparation and disposal of manufacturing records ▲failure to change manufacturing methods ▲arbitrary increase or decrease in raw material usage. In particular, Chong Kun Dang was found to have prepared false manufacturing records using the same format as the approved records for all processes from raw material weighing to completion of manufacturing in preparation for the MFDS inspection, and discarded the actual records used in manufacturing after production.

Among the nine pharmaceutical products, for the four items classified as `Supply Suspension Report Target Pharmaceuticals` ? ▲Depas Tab 0.2 mg ▲Bezallip Tab ▲Uritos Tab ▲Prigrel Tab ? considering that substitution with other pharmaceuticals is difficult in medical practice and that the content met test standards based on recall and inspection results, the MFDS, after consulting experts from the Central Pharmaceutical Deliberation Committee, decided to allow the use of products already distributed in the market for Depas Tab, Bezallip Tab, and Uritos Tab.

For the other six items ? ▲Lipilow Tab 10 mg ▲Candemore Plus Tab 16/12.5 mg ▲Neocande Plus Tab ▲Tamunal Capsule ▲Timeal Capsule ▲Prigrel Tab ? the MFDS issued a safety alert requesting cooperation to switch to alternative pharmaceuticals and ensure proper product recalls, distributing the alert to medical professionals, pharmacists, and consumers. Additionally, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, the MFDS requested that prescriptions for these items be restricted at hospitals and clinics.

The MFDS plans to continue conducting unannounced inspections of pharmaceutical manufacturing sites throughout the year via the Pharmaceutical GMP Special Inspection Team, transparently disclose the results, and promptly take necessary measures prioritizing patient safety. Through this, the MFDS intends to revoke GMP compliance certifications for intentional violations such as arbitrary changes in manufacturing methods and falsification or duplicate record preparation, and pursue amendments to the Pharmaceutical Affairs Act to impose punitive fines on unfair profits gained from such violations.