FDA Facility Registration

Issued by FDA

Registration

Audit Scope

Facility registration under 21 CFR Part 1, Subpart H. Biennial renewal required. No inspection prerequisite.

What It Proves

Facility has registered with FDA as required by law. FDA knows the facility exists and what it manufactures.

What It Does Not Prove

FDA registration is a LEGAL REQUIREMENT, not an achievement. Does NOT mean FDA has inspected, approved, or certified the facility. Does NOT mean products are safe. Every legal supplement manufacturer must be registered — advertising it as a differentiator is misleading. DMFs (Drug Master Files) are for drug manufacturing, not supplements.

How Vendors Report It

You may see this listed as:

FDA RegisteredFDA Registered (5 DMFs)

Vendors Listing This Certification

Claims are at various verification stages. See individual profiles for assessment details.

Related Glossary Concepts

21 CFR Part 111 FDA Inspection

Evaluating Manufacturer Credentials?

Our directory shows certification status, verification details, and assessment rationale for every listed vendor.

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