FDA May Refuse Taiwan Drug Products for CGMP Violations, Unapproved Marketing
The Food and Drug Administration may refuse entry of Taiwan Three Mast Pharmaceutical’s drug products for violations of Current Good Manufacturing Practice regulations, it said in a warning letter. Three Mast is also engaging in unapproved marketing of one of…
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its products, FDA said, by marketing its Imbue Pain Relief Patch as an external analgesic for treatment of tendonitis and bursitis, which are not approved uses.