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FDA Issues Safety Advisory Following Brain Injury Reports
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FDA Hits New IBM Unit With Warning Letter
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FDA Issues 483s to Theranos for Documentation, QMS Problems
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FDA Hits Troy for Process Validation, Supplier Qualification Sloppiness
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MHRA Suspends Sales of Silimed Products Following Inspection
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Hospira Device Plant Receives Form 483 for Infusion Pump Battery Failures
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Faulty Batteries, Software Glitch Lead to Recalls
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Validation Failures for Cardiac Designs Result in Warning Letter
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Design Validation, CAPA Failures Land Cepheid 483
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Cane S.p.A Gets Warning Letter Over Infusion Pump Procedures
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Rust-Like Contamination Earns Dental Company a Warning Letter
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Medtronic Allowed to Resume Swedish Sales of Insulin Pump
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