Miami University Department of Chemistry and Biochemistry Dear Dr. Tierney: 亲爱的蒂尔尼博士: The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, at Miami University, FEI 3009095423, at 651 East High Street, Oxford, from November 1 to November 5, 2021. ...
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). 由于你们...