World of Compliance Module

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  1. Is there a standard format for the 482 notice?
    1. No. A 482 form is just filled in at the top. The rest of the form is standard legal verbiage.
  2. Does FDA have an inspectional check list for different products?
    1. No, but Compliance Guidance Manual 7356002 provides some information. The manual is available online at http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm.
  3. Who pays for FDA foreign inspections?
    1. FDA pays for foreign inspections, with the exception of new drug applications which are paid through the Prescription Drug User Fee Act (PDUFA). Inspections related to generic drug applications also are paid for by FDA.
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Topic: page 8 of 8 (Lesson: page 34 of 35)