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The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components. Read More
The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues. Read More
U.K. regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination. Read More
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More