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Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More
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
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Read More
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