Refusing on-site inspection? The National Medical Products Administration will immediately deem the facility non-compliant with GMP and suspend imports!
Release Date:
2020-08-01
In accordance with the 2020 Overseas Inspections Plan for Pharmaceuticals, the National Medical Products Administration intends to conduct an on-site inspection of SANYO CHEMICAL LABORATORY CO., LTD. of Japan with respect to Methoxyphenamine Hydrochloride (English name: Methoxyphenamine Hydrochloride; Registration Certificate No.: H20160663; Manufacturing Address: 148-1, Tajii, Mihara-ku, Sakai-shi, Osaka, 587-0012, Japan). The company has submitted a written statement indicating its refusal to undergo the on-site inspection. Pursuant to the Regulations on the Administration of Overseas Inspections of Drugs and Medical Devices, such refusal shall be deemed as a circumstance of refusal to cooperate with the inspection, and the company’s manufacturing processes will be directly determined to be non-compliant with the requirements of China’s Good Manufacturing Practice for Pharmaceuticals (Revised in 2010).
In accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China, the National Medical Products Administration has decided, effective immediately, to suspend the import of methoxyphenamine hydrochloride manufactured by SANYO CHEMICAL LABORATORY CO., LTD. of Japan. The drug administration authorities at all ports of entry are hereby directed to suspend the issuance of import customs clearance certificates for this product.
Hereby announced.
National Medical Products Administration
July 29, 2020
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