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Glucose test firm's woes don't keep FDA at bay.(Diabetes ...
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`Root cause' analysis seen helpful in meeting FDA CAPA ...
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OTC maker lacks staff, equipment for assays, and ...
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Kiel Labs cited for Part 11 and OOS violations in ...
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September guidance seen forming basis of any Part 11 ...
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Holter monitor manufacturer's validation problems ...
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Schering's failure to fix six items from Jan. 2001 audit ...
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WFI can now be produced by any method other than reverse ...
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Software validation guidance gives industry flexibility, ...
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Staar Surgical cited for failure to do root cause ...
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Undocumented design change of dialysis system violates ...
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8-step approach suggested for sponsors to audit CROs. ...
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