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Articles from Inspection Monitor (January 1, 2005)

1-9 out of 9 article(s)
Title Author Type Words
D.C. blood bank gets 5-item 483 for documentation failures, not following SOPs. 495
Despite clean '03 audit, Steris acknowledges it is under federal probe related to hospital sterilizer. 932
Foreign inspections up in 2004, but overall FDA audits down 3.4% from '03. 636
Inspection log. 370
Kiel Labs 483 shows FDA still enforcing Part 11; 19-item 483 also cites OOS. 725
Mammography device maker hit with 9-item 483 and warning letter for DHR, DMR violations. 360
Old Hickory slapped with 19-item 483 for multiple violations, warning letter for labeling flaws. 722
Ortho Technology nets 9-item 483 and warning letter for CAPA flaws, QS, MDR deficiencies. 729
Wright Medical Technologies cited in 19-item 483 for quality system and CAPA flaws. 427

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