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  5. PART III - INSPECTIONAL
  1. FDA Bioresearch Monitoring Information

PART III - INSPECTIONAL

Inspections involve evaluation of the sponsor’s/CRO’s/monitor’s practices and procedures to determine compliance with applicable regulations.

 

A.            GENERAL

 

The following pertain to all inspections.

 

1.   Sponsor, CRO, and monitor inspections are product type-specific, i.e., human drugs and biologics, animal drugs, medical devices, or foods. Field investigators must apply the pertinent regulations to each inspection.

 

2.   Inspections under this program will be pre-announced unless otherwise instructed in the inspection assignment. The field investigator should keep the time span between initial contact and actual inspection as short as possible. The field investigator should immediately report to the Center contact any attempt by the sponsor/CRO/monitor to unduly delay an inspection, by more than ten working days, without sufficient justification.

 

3.   Inspection Refusals

          a.   Refusal of entry

If a sponsor/CRO/monitor refuses to permit an inspection by FDA personnel,