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Disconnect Between Management, QCU Possible Source of Warning Letters
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Canadian API Maker Warned for cGMP Failures, Will Remain on Import Alert
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FDA Steps Up Global Enforcement Actions
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Cobweb Trips up South Carolina Drugmaker
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FDA Clears Hospira to Produce Injectables at New India Plant
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Data Integrity Issues Fuel Rise In Critical Inspection Findings
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FDA Tightens Screws on Compounders
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Health Canada Launches Online Inspections Database
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CXL-USA Warned for Failure to Review Trial-Related Records
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Excipient GMP Standard Brings New Risk-Assessment Requirements
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Gilead Sciences Lands Form 483 Due to Production Issues
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Dr. Reddy’s Facility Hit With Eight-Observation Form 483
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