12 questions to ask a supplement manufacturer

01 / Who contracts with us, and who makes the SKU?

Ask for the legal entity and the physical producing site. If a partner coordinates several facilities, identify the one proposed for this format. Request a responsibility map covering production, testing, packaging and logistics. Agree how any site change will be reviewed before the order moves.

02 / What do the qualification documents cover?

Request complete, current documents and check the site address, issuing body, scope and validity. A logo on a website is not enough to establish coverage. FDA registration does not mean FDA approval. Confirm any permission needed before using a third-party certification mark on your own packaging.

03 / What are the format and equipment limits?

Connect the broad capability list to your actual product. Ask about the line, batch range, serving capacity and packaging fit. A capsule specification cannot simply be moved to a gummy or oral film. Ask which feasibility questions remain open and what sample or trial will resolve them.

04 / How are incoming materials controlled?

Ask how suppliers are evaluated and how incoming lots are identified, held and released. Specify the ingredient form, source and relevant quality attributes rather than relying on a general ingredient name. For a botanical, request the species and plant part; for a premix, understand the carriers and component information.

05 / Who develops and controls the formula?

Clarify whether the project uses an existing formula, a modified base or original development. Define access to quantitative specifications, confidentiality, ownership and transition rights. Ask how sample versions are linked to the final approved formula so that production cannot follow an earlier revision.

06 / Which tests determine acceptance?

Request a written testing plan linked to the finished-product specification. Ask for methods, limits, sample plans, laboratories and turnaround times. The panel should reflect the formula and format; a generic list of every possible test is not a substitute. Review a representative, redacted COA and agree what the actual batch COA must report.

07 / How does the specification become a batch record?

Ask how the master manufacturing record is approved and revised, and how each batch records materials, quantities, process steps, checks and packaging. FDA’s dietary supplement CGMP guidance describes master and batch production records and quality-control responsibilities. Use those requirements to guide the discussion, not a claim that any particular site has already met them.

08 / What creates the real minimum order?

Separate finished-product minimums from ingredient and packaging minimums. A printed pouch or custom component may create a larger commitment than the product itself. Ask who pays for unused components, where they are stored and what happens if the artwork changes before they are consumed.

09 / What starts—and can pause—the schedule?

Request a milestone plan with dependencies. Formula approval, material arrival, artwork, production availability and laboratory release may sit on different timelines. Confirm whether the quoted duration ends at production completion, release or shipment. Record assumptions before comparing suppliers on speed.

10 / Who approves substitutions and deviations?

Ask how a change in material source, carrier, shell, flavor, package or method is proposed and assessed. Agree which changes require buyer approval before implementation. The review should consider specifications, label text, sensory properties and schedule. Also ask how unexpected production events are investigated and communicated.

11 / What is included in the delivery handoff?

Define the documents supplied before shipment and the person responsible for reviewing them. Clarify freight scope, destination preparation and any external label or import review. “Support” is too broad for a purchase order: name the deliverable, owner and timing, and obtain market-specific advice where needed.

12 / What happens when a batch or shipment has a problem?

Ask for the escalation route, investigation process and responsibilities for complaints, retained samples and traceability records. Discuss how release is held when results need investigation. A useful answer explains who takes action and what evidence is retained; it does not promise that problems can never occur.

Turn the answers into an open-items log. Record the evidence received, the remaining gap and the person responsible for resolving it. Qualification is complete only when the agreed project requirements are addressed—not when every box contains a sales response.