MFDS Suspends Manufacture and Sale of 9 Chong Kun Dang Pharmaceuticals for 'Pharmaceutical Affairs Act Violation' (Comprehensive)

Jongkundang Headquarters (Provided by Jongkundang)

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

On the 21st, the MFDS announced this measure following the results of a special unannounced inspection conducted by the 'Pharmaceutical Manufacturing and Quality Control Standards (GMP) Special Planning Inspection Team' from the 5th of this month to the present.

Previously, after confirming illegal activities during the manufacturing processes at Binex and Vibozone Pharm, the MFDS established the Special Planning Inspection Team to conduct ongoing unannounced inspections in addition to the existing triennial regular monitoring, aiming to prevent intentional GMP violations from recurring.

The Special Planning Inspection Team conducted inspections on four companies and confirmed violations in two of them.

Among these, Chong Kun Dang was found to have violated the Pharmaceutical Affairs Act by arbitrarily using additives without obtaining change approval. The MFDS has imposed provisional manufacturing and sales suspension measures on nine pharmaceuticals either manufactured or contract-manufactured by Chong Kun Dang.

In addition to Chong Kun Dang, one other company was found to have violated pharmaceutical manufacturing and quality control standards, including failure to conduct performance tests on media used for microbial limit tests.

An MFDS official stated, "Since Chong Kun Dang's problematic pharmaceuticals require prescription restrictions, the company name and product names have been disclosed," adding, "The name of the other company will also be disclosed once the disciplinary measures for the violations are finalized." No violations of the Pharmaceutical Affairs Act were found in the other two companies inspected.

The MFDS confirmed the following violations by Chong Kun Dang during the special inspection: ▲arbitrary use of additives without change approval ▲falsified duplicate manufacturing records and disposal ▲failure to change manufacturing methods ▲arbitrary increase or decrease in raw material usage. Notably, Chong Kun Dang prepared falsified manufacturing records in the same format as the approved ones from raw material weighing to manufacturing completion to deceive the MFDS inspection, and the actual manufacturing records were discarded after production, as revealed by the inspection.

Among the nine pharmaceuticals, four items classified as 'Supply Suspension Report Target Pharmaceuticals'?▲Depas Tab 0.2 mg ▲Bezallip Tab ▲Uritos Tab ▲Prigrel Tab?were reviewed considering the difficulty of substituting them with other pharmaceuticals in medical practice and that the content met test standards based on recall and inspection results. After expert consultation by the Central Pharmaceutical Review Committee, the use of already distributed products of Depas Tab, Bezallip Tab, and Uritos Tab was permitted.

For Prigrel Tab and six other items?▲Lipiro 10 mg Tab ▲Candemore Plus Tab 16/12.5 mg ▲Neocandef Plus Tab ▲Tamunal Capsule ▲Timeal Capsule?since alternative pharmaceuticals are available, substitution is recommended. A safety alert requesting cooperation to ensure proper product recall was distributed to medical professionals, pharmacists, and consumers, and the Ministry of Health and Welfare and the Health Insurance Review & Assessment Service were asked to restrict prescriptions of these items at hospitals and clinics.

A Chong Kun Dang representative stated, "We plan to actively reflect on the MFDS's pointed issues and make proper improvements as soon as possible."

The MFDS will continue to conduct year-round unannounced inspections of pharmaceutical manufacturing sites through the GMP Special Planning Inspection Team, transparently disclose the results, and promptly take necessary actions prioritizing patient safety. Through this, intentional violations such as arbitrary changes in manufacturing methods and falsified or duplicate record-keeping will lead to cancellation of GMP compliance certification, and punitive fines will be imposed on unfair profits gained from such violations. Amendments to the Pharmaceutical Affairs Act will be pursued accordingly.