DISTRICT COMPLIANCE UPDATE

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InspectionsForeign and Domestic Fiscals Years
1993 2003
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RecallsFiscals Years 1993 2003
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InjunctionsFiscals Years 1993 2003
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SeizuresFiscals Years 1993 2003
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Warning LettersFiscals Years 1993 2003
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WHAT SITUATIONS WARRANT FOLLOWUP

• SERIOUSNESS OF PROBLEM
• WILLINGNESS OF FIRM TO CORRECT
• SYSTEM(S) OUT OF CONTROL
• ADULTERATED/MISBRANDED PRODUCT
• PATTERN 0F FAILURE

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CONTACT

• SCOTT J. MacINTIRE
• Scott.MacIntire_at_FDA.HHS.GOV
• 312-596-4200