Sunday, February 22, 2009

what are Firm’s Inspectional Policies during fda inspections

  • Cameras or recording devices are strictly prohibited
  • Maintain Documentation Integrity-GXP documentation shall not be defaced
  • All Documentation given to FDA shall be first stamped- “Confidential” or “Proprietary” Information
  • Employees shall not sign any documented presented by FDA or an Official
  • Affidavits or other official FDA documents shall be courteously refused

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