Guide
Which compliance questions should you ask before signing a contract manufacturer?
By Jake, founder · Published · Updated
Before signing, ask a contract manufacturer seven things: its facility registration attestation, its cGMP certificate and who issued it, exactly what its standard per-lot COA covers and omits, its turnaround for document requests, whether it will sign a quality agreement, how it handles specification changes, and for a complete sample document set.
Price, minimums, and lead time decide most contract manufacturing choices. The compliance questions below decide something different: how expensive this relationship becomes the first time a platform, retailer, or auditor asks your brand for its file. Every question is answerable before signing, in writing, at no cost, which is precisely when manufacturers answer them most readily. The list is written to be sent as-is.
The seven questions
- What is your FDA facility registration number, and will you provide a written attestation of current registration? FDA's food facility registration database is not public, so you cannot look this up; the attestation is the verification mechanism. Registration renews biennially (even years), so ask when it was last renewed and expect a refreshed attestation each cycle.
- Are you cGMP certified, and who issued the certificate? Ask for the certificate itself, its expiry date, the issuing body, and confirmation that it covers the specific facility that will manufacture your product, not a sister site. A certificate is only as strong as its issuer, and downstream reviewers weigh that.
- What does your standard per-lot COA cover, and what does it omit? Request the actual template. Many standard COAs cover identity and basic quality checks but omit test categories a platform review expects; the gap surfaces during a review, when closing it costs a fresh testing cycle at roughly $500 to $1,000 per product instead of a document request. Compare the template line by line against what your channels require, and agree in writing on any additions before the first production run.
- What is your turnaround for document requests?Not production lead time, but document lead time. When your brand is asked for a COA copy, a certificate, or an attestation, how many business days until it arrives, and who is the named contact? Platform reviews run on the requester's clock; a manufacturer that takes three weeks to forward a PDF sets your response time for you.
- Will you sign a quality agreement? The agreement allocates tasks: who sets and holds specifications, who performs which tests, who retains which records and for how long, who notifies whom of deviations and changes. Responsibility for the product remains with your brand regardless, and a quality agreement cannot transfer it, but the task allocation is exactly what prevents documentation gaps. Reluctance to sign one is information.
- How do you handle specification changes? Ingredients get re-sourced, formulations get adjusted, suppliers change. Ask how changes are proposed, who approves them (it should be you), how they are documented, and whether changed lots are identifiable. An unannounced spec change is how a brand ends up selling a product its documents no longer describe.
- Can you send a complete sample document set now? For a comparable product: the per-lot COA exactly as issued, the cGMP certificate, and the registration attestation. The sample shows you what you will actually receive every lot (formatting, completeness, units, lab details) before you have committed. Review it the way a TIC provider would; a set that would bounce a verification today will bounce one when it matters.
FDA facility registration renewal window: 10-01 to 12-31, even years. Last verified 2026-07-24.
Reading the answers
The content of the answers matters less than their character. A manufacturer that responds inside a week, in writing, with current documents attached, is showing you what every future document request will look like. A manufacturer that answers vaguely, or by phone only, or with documents that are expired or partial, is showing you the same thing. You are not only evaluating the answers; you are rehearsing the relationship.
Why this is worth an email before signing
Once you are selling, every gap in this list converts into money and downtime at fixed exchange rates: a missing or stale COA becomes fresh testing at roughly $500 to $1,000 per product instead of a $80 to $120 review; a slow document turnaround becomes days of suspension you cannot shorten; an omitted test category becomes a review failure you learn about from the platform rather than from your own file. All seven questions cost one email. The answers are the cheapest compliance work you will ever do.
Cost figures last verified 2026-07-24, from published TIC provider and third-party laboratory price sheets. They are configuration, not constants: providers change their pricing.
Frequently asked questions
- What compliance documents should I ask for before signing with a contract manufacturer?
- At minimum: a written attestation of FDA facility registration (the registration database is not public, so attestation is the verification mechanism), the facility's current cGMP certificate with its issuing body named, and a complete sample document set for a comparable product, exactly as you would receive it per lot.
- Why does it matter who issued the manufacturer's cGMP certificate?
- Because certificates vary in rigor and recognition. A certificate is only as strong as its issuer, and reviewers weigh the issuing body. Ask who issued it, when it expires, and whether it covers the specific facility that will make your product.
- What do standard manufacturer COAs commonly leave out?
- Many standard per-lot COAs cover identity and basic quality checks but omit test categories a platform review expects to see. The omission is discovered during a review, when it is most expensive. Ask for the standard COA template up front and compare its scope against what your sales channels require.
- Is a quality agreement worth insisting on before signing?
- Yes. A quality agreement allocates the documentation tasks: who tests what, who holds which records, who notifies whom of changes. A manufacturer's willingness to sign one is itself diagnostic; responsibility for the product stays with your brand either way, so you want the task allocation in writing.