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Articles from Inspection Monitor (March 1, 2001)

1-9 out of 9 article(s)
Title Author Type Words
Akorn digs out from under 21-page EIR, warning letter. Brief Article 734
Details bedevil maker of compression garments. Brief Article 896
FDA leveraging necessary for inspector techno-savvy. Brief Article 813
Handling of study drug is focus of BiMo audit. Brief Article 647
Holy Cross Hospital IRB flunks Part 11 plus other BiMo-related procedures. Brief Article 924
INSPECTION LOG. Brief Article 911
IRB clears audit, asks about expedited phase IV review. Brief Article 987
Organon cited for OOS, SOPs; gets warning letter. Brief Article 937
Tube maker tangles with FDA over EtO validation. Brief Article 791

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