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The FDA issued a warning letter to NuCare Pharmaceuticals in Orange, California for failing to fix drug listing deficiencies in the agency’s database. Read More
Texas drugmaker Isotherapeutics was hit with a Form 483 for multiple violations at its Angleton facility, including problems with its cleanrooms. Read More
The FDA issued a warning letter to a South Korean OTC manufacturer Dermameal for violations at its facility in Gyeonggi-do, including the incomplete quality testing and an inadequate stability program. Read More
Fort Worth drugmaker CBI Laboratories was slapped with a Form 483 for multiple violations at its facility including a flawed quality unit, the lack of annual product reviews and a failure to conduct cleaning validations. Read More
The FDA issued a warning letter to a Chinese drugmaker for significant cGMP violations related to identity testing, process validation and its written stability program. Read More
Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the FDA’s Form 483 inspection observations made public on Tuesday. Read More
Staff admitted that the facility stopped testing for the active ingredient because they had “previously obtained consistent passing results,” the agency said. Read More