China NMPA Discloses Findings from Unannounced Inspection of a South Korean Company

On August 13, 2024, China's National Medical Products Administration (NMPA) released the results of an unannounced inspection conducted on a South Korean cosmetic company. The inspection uncovered several regulatory violations, including the failure to implement a compliant product release management system and the absence of a supervision system for the production activities of its contracted manufacturers. These issues were in breach of regulations such as the Cosmetic Supervision and Administration Regulation (CSAR) and the Supervision and Administration Measures on Cosmetics Manufacture and Operation.

The Chinese domestic responsible person of the company is based in Zhejiang province, so NMPA has directed Zhejiang Medical Products Administration (MPA) to ensure that the company rectifies these deficiencies. If any suspected illegal activities are discovered, Zhejiang MPA is required to file a case for investigation in accordance with the law.

ChemLinked Comments

Overseas inspections have always been one of the focuses of overseas cosmetic manufacturers. Industry experts note that unannounced inspections by Chinese regulators are risk-based and often focus on companies that are frequently found to have problems or non-compliance in product registration/notification, inspection, adverse reaction monitoring, complaints and reporting, etc., as well as companies with large product imports, large consumer bases and significant market influence in China.

In terms of product category when selecting unannounced inspection targets, children's special products have a higher priority than children's general products, followed by special products for the general population and then general products for the general population.

Overseas manufacturers are advised to closely review their quality control systems and production management practices to avoid potential regulatory violations.

Further Reading

• First Unannounced Inspection Failure of Foreign Company, Unveiled by China NMPA

• China Consults on Draft Regulations for Cosmetic Overseas Inspection

• Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft)