The Australian Council on Healthcare Standards (ACHS), Australia's leading independent authority on healthcare, has recognised the high standard of care that Fresenius Medical Care provides to patients by awarding accreditation to the company's network of 16 dialysis clinics, with clinics achieving the highest possible rating 'Met with Merit' in five important areas.
Sekisui Medical On Health Canada Inspection List
The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).