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This page includes information provided to
FDA investigators and inspectors to assist them in their daily activities.
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The primary vehicle for distributing procedural information/policy on the management of
Office of Regulatory Affairs (ORA) field activities.
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Guidance documents written to assist FDA personnel in applying FDA's regulations,
policies and procedures during specific types of inspection or for specific manufacturing
processes.
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 March,
2004! Primary procedure manual for FDA personnel performing
inspections and special investigations.
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Procedure manual for FDA personnel performing inspections and other FDA-related activities
abroad.
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Guidance documents that provide FDA personnel with technical background in a specific
piece of equipment. or a specific manufacturing or laboratory procedure, or a specific
inspectional technique, etc.
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(link to page maintained by CDRH)
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