FDA compliance program

INSTITUTIONAL REVIEW BOARD (IRB/IRC)

FDA program assignment code 41809 · Biologics (CBER)

Key facts

Program assignment code (PAC) 41809
Program INSTITUTIONAL REVIEW BOARD (IRB/IRC)
FDA center Biologics (CBER)
Program area and operations Domestic Inspection, Human Cellular, Tissue, and Gene Therapies, INSPECTION Domestic Remote Regulatory Assessment, Human Cellular, Tissue, and Gene Therapies, Domestic Remote Regulatory Assessment Foreign Remote Regulatory Assessment, Human Cellular, Tissue, and Gene Therapies, Foreign Remote…

At a glance

  • 100–999 FDA inspections under this program

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA compliance programs (program assignment codes)

FDA inspections and field assignments are planned under compliance programs. Each one is coded with a program assignment code (PAC) that ties it to a program in the FDA Compliance Program Guidance Manual (CPGM).

Source: U.S. Food and Drug Administration (FDA), Compliance Program Guidance Manual and inspection data

Browse all FDA compliance programs (program assignment codes)