Inspections and Audits

Texas Firm Hit for Cleaning, Product Reviews

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

AveXis Issues Detailed Response to Zolgensma Form 483

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