FD&C Act Section 510 - Registration of Producers

What it says

Every person who owns or operates an establishment engaged in the manufacture, preparation, propagation, compounding or processing of a drug must register with FDA and provide a list of every drug manufactured, prepared, propagated, compounded or processed at that establishment for commercial distribution.

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

What it means in practice

• Establishment registration is a foundational, ongoing obligation distinct from any specific product approval - a facility must be registered regardless of which specific products it manufactures, and product listing must be kept current as the facility's manufacturing activities change.
• This registration data is what allows FDA to know which facilities exist and what they manufacture, forming the basic inventory underlying risk-based inspection scheduling and facility oversight generally.
• Foreign establishments manufacturing drugs for the US market are also subject to this registration requirement, connecting directly to FDA's ability to schedule and conduct foreign facility inspections.

What FDA inspectors look for

• This is a foundational registration obligation rather than a specific manufacturing practice - its practical connection to inspection readiness is that registration and product listing information must be accurate and current, since discrepancies can raise questions about undisclosed manufacturing activities.
• Whether a facility's actual manufacturing activities match what is reflected in its current FDA registration and product listing.

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