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Articles from Inspection Monitor (January 1, 2008)

1-10 out of 10 article(s)
Title Author Type Words
5-item 483 handed to Sunoptic for unvalidated processes. 628
Clinical investigator clears FDA audit after protocol deviations noted. 324
Clinical investigator has clean audit, one note about vital signs taken late. 312
Clinical investigator re-inspection nets clean inspection report. Clinical report 459
Foreign/domestic drug GMP inspections drop 106 from '06. 363
Inspection log. 283
LifeCare Technologies hit with 8-item 483 for inadequate software validation. 1103
Maier slapped with 3-citation 483 for case history flaws, not reporting adverse events. 472
Stroup fails to follow investigational plan, notes 3-item 483. 503
Underwood slapped with 2-item 483 for failing to keep accurate study records. Clinical report 667

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