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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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Compounders Face Murder Charges over Poor Quality
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FDA Quality Metrics Program Delayed, Extended to Biologic Products
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FDA Inspection Gave Beleaguered GVK Bio Plant Clean Bill of Health
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U.S. FDA May Recognize Firms That Go Extra Yard in GMP Compliance
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2014: A Year Focused on Transparency, Drug Safety and a Crisis in West Africa
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Drugmakers’ Guide to Global Quality API Manufacturing
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Understanding EU Drug Safety Reporting
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Poor Investigations Doom API Maker to Form 483
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Expediting the FDA Generic Drug Approval Process
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