FD&C Act Section 704 - Factory Inspection Authority

What it says

Section 704 grants FDA officers and employees the authority to enter and inspect, at reasonable times and within reasonable limits, any factory, warehouse or establishment in which drugs are manufactured, processed, packed or held, including all pertinent equipment, materials, containers and labeling.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This is the specific statutory basis granting FDA the legal authority to conduct the facility inspections that produce the 483 observations, warning letters and other enforcement actions discussed throughout this library.
• Inspection authority under this section extends to records as well as physical facilities, though the scope of records access has been subject to legal interpretation and, more recently, expanded through the QMSR alignment with ISO 13485:2016 for device manufacturers.
• Refusing a properly authorised inspection under this section carries its own serious legal consequences, generally treated as at least as serious as whatever the inspection itself might have revealed.

What FDA inspectors look for

• This is the statutory authority underlying the inspection process itself rather than a specific practice inspectors check for - its practical relevance is that a site's inspection-readiness posture assumes and depends on this legal authority being properly understood and respected by the facility being inspected.
• Whether facility personnel understand their obligations regarding inspection access and records production, avoiding both improper refusal and unnecessary over-disclosure beyond what is actually being requested.

Related regulations