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St. Jude Gets Short 483 on Test Method Validation
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Medtronic Handed Form 483 on CAPAs, Inspections
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Baxter 483 Covers CAPA, Risk-Assessment Issues
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Med-Mizer Warned for MDR Failure After Patient Wedges Head, Dies
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FDA to Spacelabs: Get Consultant to Audit on CAPA, MDR Issues
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Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps
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