FDA Drug Establishment Registration
Administered by FDA
RegistrationAudit Scope
Drug establishment registration and drug cGMP compliance under 21 CFR Parts 210/211. Higher requirements than supplement GMP.
What It Proves
Facility is registered with FDA as a drug establishment and subject to the drug cGMP regime (21 CFR 210/211), a stricter standard than the dietary supplement regime (21 CFR 111).
What It Does Not Prove
Does NOT mean supplement products made at the facility follow drug-level GMP. Supplement lines may operate under the lower Part 111 standard even in a drug-registered facility. FDA establishment registration is not a license, approval, or endorsement — FDA does not issue drug-manufacturing 'licenses,' and registration does not denote FDA approval (21 CFR 207.77).
How Vendors Report It
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