"FDA registered" means a food facility registration was filed; FDA issues no certificate, keeps the list confidential, and says the number conveys no approval. Inspection history is public on the FDA Data Dashboard, warning letters on fda.gov. A cGMP certificate comes from a private auditor (NSF, UL, USP), never from FDA, and proves a site passed an audit on a date, not that your product meets its specification. Check each claim at its source, then get scope and responsibilities in writing.
| Claim | What it actually proves | Where to verify | Steps |
|---|---|---|---|
| "FDA registered" | A food facility registration exists. No approval, no inspection implied | Not searchable: FD&C Act 415(a)(5) exempts the list from public disclosure and FDA issues no certificate | Ask for the registration number and the date of the last biennial renewal (October 1–December 31 of even-numbered years). Match the legal name and address to your contract |
| "FDA inspected" or "no 483s" | An inspection outcome on a date | FDA Data Dashboard, Inspections; FDA Inspection Classification Database | Search the firm name; read the classification (NAI, VAI, OAI) per project area. Letters issue 45–90 days after close; state-contract inspections are excluded |
| "No warning letters" | Absence from a public list | fda.gov Warning Letters | Search company name; filter by issuing office and year; export XLSX for the file |
| "cGMP certified" | A private auditor's opinion on an audit date | NSF Certified GMP Facilities listing; UL (successor to the NPA program); USP GMP audit | Ask for the certificate: standard (NSF/ANSI 455-2, NSF/ANSI 173, 21 CFR 111), site address, scope, audit date, expiry. Confirm on the auditor's listing |
| "USP Verified" | A specific product passed identity, potency, contaminant and performance testing plus a GMP audit | USP Verified Mark program | Product-level only; a verified SKU says nothing about a different product from the same line |
| "Third-party tested" | Somebody ran some tests | The certificate of analysis | Ask for lab name, method, specification, lot number and who approved it |
Begin with the legal entity and the site
Ask which legal entity signs, which physical site performs development, casting, converting, packaging, storage and release, and which steps are subcontracted. Match the address on the quotation to the address on every certificate and record you are shown. A website can list activities from three buildings as if they were one.
Registration is a filing, not an approval
A US supplement or food facility must hold a food facility registration. FDA's own Q&A is direct: no certificate is issued, and a registration number "does not in any way convey FDA's approval or endorsement of a facility or its products." The list is not public; section 415(a)(5) of the FD&C Act exempts it from disclosure, so a buyer cannot look a registration up. The facility may disclose its own number, and FDA expects suppliers and customers to settle the question between themselves.
So a framed "FDA registration certificate" came from the vendor or a filing agent, not FDA. Ask for the number and the last biennial renewal instead. Our own position: StripWorks holds no certifications and says so; registration status and quality records are shown on request.
Read the inspection record yourself
The FDA Data Dashboard lets you search a firm and see each inspection's classification: NAI (no action indicated), VAI (voluntary action indicated, usually with a Form 483), or OAI (official action indicated, an unacceptable state of compliance). Final classification letters go out 45–90 days after an inspection closes, and state-conducted and pre-approval inspections are excluded. The Warning Letters page on fda.gov is searchable by company, issuing office and year, and exports to a spreadsheet.
A facility with no record is usually one that has not been inspected, not a clean one. Ask when the last FDA or state inspection took place and whether a 483 was issued.
What a cGMP certificate does and does not prove
FDA does not issue cGMP certificates; third-party programs do. NSF audits registered facilities twice a year against 21 CFR 111, now under NSF/ANSI 455-2, and publishes a searchable list. UL runs the program that grew out of the Natural Products Association's. USP offers a facility GMP audit and the product-level Verified Mark, which adds testing for identity, potency, contaminants and disintegration or dissolution.
A certificate proves one site passed one audit on one date, for the scope printed on it. It does not prove your formula, your methods or your specification. Use it to shorten your own audit, not to skip it.
Define testing and release responsibilities
Ask who writes the specification, selects methods and laboratories, approves sampling, receives results, investigates out-of-specification findings and authorizes release. A certificate of analysis is useful when the lot, methods, specifications, results, laboratory and approvals are all readable on it. Ours come from ILS Lab inside the Lot Release Packet for each lot.
Trace one hypothetical lot
Walk it from supplier qualification and ingredient receipt through dispensing, casting, in-process checks, converting, sachet and carton control, reconciliation, coding, testing, review, release, shipment, retained samples, complaints and recall readiness. Gaps a capability list hides show up in twenty minutes of this.
Worked example: checking a two-line claim
A quotation says "FDA registered, cGMP certified." Step one: ask for the registration number and renewal date; there is nothing to look up. Step two: search the firm on the FDA Data Dashboard and the warning-letter page. Step three: ask which body issued the cGMP certificate, find the site on that body's public listing, and compare address, standard and expiry. A different address, a lapsed date, or a standard the vendor cannot explain means the claim is decoration. If everything matches, you have confirmed the site's status and learned nothing yet about your product's specification. That comes from the quality agreement.
Put scope and change control in writing
The proposal or quality agreement should state ingredient sourcing, development rounds, specifications, artwork approval, packaging components, tests, documents, acceptance criteria, quantity, overrun and underrun rules, storage, release, shipping and reorder requirements, and name who approves any change to supplier, site, material, formula, test, package or process before use.
Score evidence, not badges
Score evidence quality, product-scope fit, technical communication, responsibility clarity, documentation, testing, packaging integration, pilot plan, change control and commercial readiness. Record open questions with owners. The right partner is the one whose verified scope fits your product, not the one with the longest logo strip.
Common questions
No. Section 415(a)(5) of the FD&C Act exempts the list and registration documents from disclosure. Ask the facility for its number; it is free to share it.
It covers the site and scope printed on it, on the audit date. Product-level assurance comes from your specification, your release testing and a product program such as USP Verified.
Official action indicated: FDA judged the facility to be in an unacceptable state of compliance at that inspection. Ask what was cited and what was corrected before going further.
Primary sources
- FDA — Questions and Answers Regarding Food Facility Registration (Seventh Edition), sections L and M
- FDA — Is It Really 'FDA Approved'?
- FDA — Data Dashboard: Inspections
- FDA — Inspection Classification Database (NAI, VAI, OAI definitions)
- FDA — Warning Letters
- FDA — Dietary Supplement CGMP Small Entity Compliance Guide (21 CFR Part 111)
- NSF — Certified GMP Facilities listing
- NSF — NSF/ANSI 455-2 dietary supplement GMP certification
- USP — Dietary Supplement Verification Program and Verified Mark
- Natural Products Association — Federal GMPs for dietary supplements
- Business Wire (2020) — UL Registrar GMP certification program announcement
Formula feasibility, packaging, testing, claims, timing, and final quantities depend on the exact product. Use this guide to prepare better questions, then confirm the production plan for your project.