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The National Drug Administration recently conducted an on-site inspection of pharmaceutical production abroad by the National Drug Administration for injection of yew alcohol (albumin-binding type) at Celgene Corporation of the United States .IXIC FOR Injection (Albumin Bound), registration number: H20130650, entrusted manufacturer: Fresenius Kabi USA, LLC, production address: 2020 Ruby Street, Melrose Park, IL 60160, USA.
, the product part of the key production facilities do not meet the basic requirements of China's drug production quality management, there are production process sterile control measures are not in place and other issues, does not meet China's "pharmaceutical production quality management norms (revised in 2010) requirements."
in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, the State Drug Administration has decided to suspend the import, sale and use of Celgene Corporation's injectable yew alcohol (albumin-binding type) from now on.
the drug supervision and administration department sat in the port location sit u.s.
.