Chinese pharma company slapped with import ban by FDA
- Zhejiang Hisoar Pharmaceutical on Wednesday was added to the FDA's import ban list due to GMP violations at its Taizhou City facility.
- Hisoar makes pharmaceutical ingredients for major international drugmakers, including Novartis, Sanofi, and Pfizer.
- Forty other Chinese pharmaceutical companies have previously been added to this particular import ban list.
The FDA added Hisoar to a list designated "Detention without physical examination of drugs from firms which have not met drug GMPs." In addition to the 41 Chinese firms, this so-called "red list" also includes companies based in countries around the world, including India.
The ban bars the importation of all products manufactured by Hisoar at its Taizhou City facility, according to Bloomberg.
Chinese and India pharmaceutical suppliers have come under increased scrutiny recently, as regulators and lawmakers in the United States have grown more concerned about the quality of manufacturing.
Just three weeks ago, the FDA issued a warning letter to another Chinese pharma company located in Zhejiang province. The company, Zhejiang Hisun Pharmaceutical, was flagged for deficient data controls and failure to conduct microbiological testing. Hisun is also on the same import ban list as Hisoar.
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