When can an FDA inspector conduct an inspection without a search warrant?

An FDA inspector can conduct an inspection without a search warrant during normal business hours, which typically refers to the standard operating hours of a business when personnel are present and records are accessible. This practice allows inspectors to efficiently assess compliance with regulations, ensuring that they can gather necessary evidence and evaluate operations while minimizing disruptions.

Inspections must be performed during these business hours to respect operational activities and the rights of the entity being inspected. This framework balances the FDA’s authority to enforce regulations with the need for businesses to function without undue interference. Therefore, the requirement for inspections to occur during normal business hours is essential for both regulatory enforcement and operational efficiency in the context of FDA authority.