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Poor Validation of APIs Result in 483 for Manufacturer
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Lax Water Testing Lands Generic Drugmaker 483
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GSK Biologicals Gets 483 For Persistent Mold Problem
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Chinese API Manufacturer Warned for Data Integrity
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Ranbaxy’s Injectable Antibiotic Drug Banned From EU
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U.S. FDA May Recognize Firms That Go Extra Yard in GMP Compliance
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Drugmakers’ Guide to Global Quality API Manufacturing
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Quality Risk Management for Pharmaceuticals
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Expediting the FDA Generic Drug Approval Process
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FDA Warns Italian API Maker for Deleting Quality Data
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Compounding Pharmacy Relents to FDA’s Recall Request
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FDA Issues Safety Alert for Texas Compounder’s Products
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