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October 2019

No. 327


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA’s Top Ten GMP Inspection Findings for FY 2019

An FDAnews analysis of the FDA’s GMP inspection reports for fiscal 2019 shows that drugmakers continue to stumble at the same old hurdles. Read More

Online Pharmacy Urges FDA to Pull All Ranitidine Products

Online pharmacy Valisure petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., claiming it found high levels of NDMA across multiple manufacturers and dosage forms. Read More

Warning Letter Roundup: Three Firms Slapped for Quality Issues

The FDA hit three overseas drugmakers for violations at their facilities that included testing deficiencies, a lack of cleaning validation and other slipups. 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. Read More

FDA Offers More Time to Join Quality Metrics Feedback Program

The FDA has reopened the submission period for its quality metrics feedback program, giving potential participants more time to sign up. Read More

FDA Warns Galt Pharmaceuticals for Misleading Email

The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for sending an email to doctors about its insomnia pill Doral (quazepam) that left out the fact that the drug is a benzodiazepine, a class-four controlled substance. Read More

483 Roundup: Five Companies Cited for Various Problems

Five drugmakers were cited in FDA inspections for violations that ranged from inadequate smoke studies to a “cascade of failure” at one facility. Read More