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Kiss Your FDA Regional Office Goodbye: Big Changes Afoot Thanks To ORA’s Inspectional Program Alignment

FDA’s five regional offices will be made whole and its 20 district offices scrambled under the Office of Regulatory Affairs' plan to align facility inspections along commodity-specific product lines, an agency official says – one of several bits and pieces of information trickling out about the coming scheme. “This is the most dramatic change that ORA has experienced, maybe in its history,” says Sean Boyd, acting deputy director in CDRH’s Office of Compliance.

FDA’s five regional offices will be folded into one national bureau, while its 20 district offices will be scrambled under the Office of Regulatory Affairs’ scheme to align facility inspections along commodity-specific product lines. Although the brick-and-mortar district offices will remain, the investigators who work inside will likely change.

The agency’s “field operation is oriented along geographically aligned districts and regions. This will go away under 'program alignment,'” said Sean Boyd, acting deputy director in CDRH’s Office of Compliance

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