After a warning letter and two failed inspections, the FDA called in the big guns, requesting that U.S. marshals seize an unapproved, misbranded scar removal drug marketed by Crescendo Therapeutics.
The Vista, Calif.-based company was put on notice in November when the FDA sent it a warning letter for illegally marketing HybriSil (methylprednisolone acetate), a prescription topical corticosteroid, and for doing so without a documented postmarket adverse experience reporting system.
The agency also considers the drug misbranded because its labeling does not contain adequate directions for its intended uses, the November letter states. The violations were discovered during an April 2011 inspection.
Marketing and branding mistakes are easy slips ups that can occur if you don’t know the correct procedures and hoops you have to jump through as a drugmaker. You’re far less of a target for warning letters and 483s when you have answers to questions like these. Here’s where to find them.
FDA Drug Enforcement: An Analysis of Warning Letter Trends gives you access — and insight — into all device warning letters published in 2011.
Remember, there are more audits now than ever. If you’re targeted, you’ll be facing better-trained inspectors. Learn from others’ mistakes and order this book today!