FDA Drug Manufacturing License
Issued by FDA
RegistrationAudit Scope
Drug manufacturing facility licensing under 21 CFR Parts 210/211. Higher requirements than supplement GMP.
What It Proves
Facility is licensed to manufacture drugs under stricter FDA drug GMP requirements (21 CFR 210/211), which exceed dietary supplement requirements (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-licensed facility.
How Vendors Report It
You may see this listed as:
FDA Drug License
Vendors Listing This Certification
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