FDA registered facility

An FDA registered facility in Leicester for dietary supplements

British VitaTech is an FDA registered food facility for dietary supplements. Our Leicester site is registered with the US Food and Drug Administration (FDA), and as an FDA registered facility we make custom and private label supplements there for brands that sell in the US. We build each product, its US label and its document file together, so your importer, your marketplaces and your retail buyers get what they ask for. We are ISO 9001, HACCP and GMP certified by BSI, and FDA registered.

US law deems a dietary supplement to be a food, so every facility that makes supplements for US consumers, at home or abroad, registers with FDA before it starts, unless it is exempt. A facility outside the US names a US agent as its link with FDA, assures FDA that it may inspect, and renews every two years. Registration is a legal requirement, not an approval: FDA states that a registration number does not convey its approval or endorsement of a facility or its products, issues no certificate of registration and does not approve supplements before sale. So describe us as FDA registered, never as approved or certified by FDA.

Dietary supplements only

Our registration covers dietary supplements. As of October 2026, FDA's position is that CBD cannot be sold as a dietary supplement in the US, so our US supplement programmes leave it out. Cosmetics need their own registration under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which requires cosmetic manufacturers and processors to register their facilities and the responsible person to list each product with FDA. Our food facility registration does not cover cosmetics, so we register our Leicester facility under MoCRA as US programmes from our skincare and cosmetic manufacturing range start.

Your US importer's duties, and what we prepare for each

Registration lets us make your product for the US market. The duties around each shipment sit with your US importer, and we prepare for each one during development, not at the dock.

Prior notice for every shipment

FDA must receive prior notice before each food shipment arrives, usually filed by your importer or its customs broker, and the notice asks for the manufacturer's FDA registration number. We share ours with you and your importer in confidence. Each shipment leaves with its batch code, certificate of analysis and batch release confirmation, so the paperwork matches the goods.

Foreign supplier verification by your importer

Under FDA's Foreign Supplier Verification Programs (FSVP) rule, your US importer verifies its foreign suppliers. For finished supplements, it checks that our processes give the same public health protection as FDA's supplement manufacturing rule, through an onsite audit, sampling and testing, a review of our food safety records or another appropriate activity. We supply the specification, batch records and certificates of analysis that verification draws on, and we host your importer's auditor on site when its programme calls for an audit.

Manufacturing practice under 21 CFR Part 111

FDA's dietary supplement manufacturing rule, 21 CFR Part 111, applies to supplements made abroad for the US as well as those made there. For every US product we prepare what it expects: written specifications for identity, purity, strength and composition, limits on contamination, a master manufacturing record, a batch production record for every batch, and reserve samples. Our GMP certificate is BSI's HACCP and GMP certificate, built on Codex Alimentarius food hygiene principles and covering food supplements in capsules, gummies, pouches and liquids. Amazon's US GMP verification needs a third-party 21 CFR Part 111 audit, which we plan around our US programmes. FDA also expects a brand that has its supplements made for it to know how they are made, so you receive the records that show it.

Marketplaces

We make products for Amazon US and TikTok Shop US and prepare the documents each asks for. As of October 2026, Amazon's US store requires dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organisation before they are eligible for sale, and TikTok Shop's US rules ask for a recent test report from an approved laboratory. Our guide to supplements for Amazon and TikTok Shop explains what each marketplace asks for.

Keeping the registration current and making your US product

For US brands, we make capsules, softgels, tablets, gummies, powders, sachets and stick packs, and liquids in Leicester. Capsules, gummies and liquids are GMP certified, and every format follows the same US records, testing and release.

Keeping the registration current

Our registration names our Leicester facility, its food product category (dietary supplements), our unique facility identifier, our US agent and the inspection assurance. We update it whenever those details change and renew it inside the window in every even-numbered year, because a registration that is not renewed expires and FDA cancels it. It is current to 31 December 2026, and our renewal for the 2026 window is under way (October 2026).

How we make your US product

Every US product runs through the same controlled sequence, recorded as it happens on our digital quality platform, so the batch record is complete the moment the batch is made.

1. US screen. Before formulation, we check every ingredient's US status, including new dietary ingredient status, and the state rules that touch your category.
2. Specification. Agreed during development: the formula, the label claims, the checks quality control runs on every batch and the laboratory tests for your product and markets.
3. Goods-in. Every material comes from a supplier approved before use, and we record each supplier lot and certificate of analysis. We verify the identity of every dietary ingredient before use, as Part 111 requires, with the test written into the specification and run by accredited partner laboratories.
4. Make. Materials are weighed against the batch record under our allergen management plan, then blended and encapsulated, compressed into tablets, cooked and deposited as gummies, or filled as powders and liquids, with in-process checks on weight and uniformity.
5. Label. Label verification on every batch is the critical control point in our HACCP study: ingredients, allergen declarations and batch coding are checked before release.
6. Test and release. Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order, and gummies get an active assay on every batch as standard. Quality control releases each batch against its specification, and nothing is dispatched without quality control sign-off.

Retained samples and traceability

Part 111 expects reserve samples to be kept for one year past the shelf life date where products carry one. We keep three retained samples per batch for shelf life plus one year, and every batch traces from supplier lot to dispatch, with a full mock recall, forward and backward with mass balance, in seconds.

The US document set, from registration number to label review

For a US project, you receive:

• FDA registration details: our registration number, shared in confidence for prior notice and your importer's files. FDA keeps registration numbers confidential, and we never publish ours.
• Specification and batch records: the agreed product specification, the quality control release for each batch and the records your importer's FSVP verification draws on.
• Certificates of analysis: results for every batch from accredited partner laboratories, with the method, result and specification limit for each test, as our page on supplement testing and batch release sets out.
• Stability data: the results behind the shelf life printed on your US label.
• US label review: your Supplement Facts panel, statement of identity, allergen declaration and claims checked against FDA's labelling rules before artwork is final, with structure/function claims carrying the FDA disclaimer.
• Our quality pack: copies of our BSI certificates, a HACCP summary and a worked traceability example, shared under confidentiality.

Our BSI certificates are public: ISO 9001 under certificate FS 822806, and HACCP and GMP under certificate HACCP 827076. Our page on quality and accreditations sets out each scope, and our guide to supplement manufacturing for US brands covers US labels, claims and state rules. Request our quality pack to see the full set before your first order.

Unannounced inspections, renewal and your next US product

Our next renewal window runs from 1 October to 31 December 2028. FDA is expanding unannounced inspections at foreign food facilities (announced May 2025), so we keep every batch record, retained sample and traceability file ready to show at any inspection. Our status: BRCGS implementation under way, certification expected in early 2027. Our guide to BRCGS certification explains what it adds, and our supplement regulation watch tracks each US change with its date and source.

The risks are confusing registration with approval and missing the renewal window. For your next US product, choose a registered manufacturer, ask to see its specifications and records before you commit, and write your importer's needs into the brief. We build all of it into development from the first sample.

References: Federal Food, Drug, and Cosmetic Act, section 415, 21 U.S.C. 350d (2002); 21 CFR Part 1, Subpart H, registration of food facilities (2026); 21 CFR Part 1, Subparts I and L, prior notice and Foreign Supplier Verification Programs (2026); 21 CFR Part 111, dietary supplement manufacturing practice (2026); US FDA, Dietary Supplements: How FDA Helps Keep You Safe (2022); US FDA, regulation of cannabis and cannabis-derived products, including CBD (2024); US FDA, expanded use of unannounced inspections at foreign manufacturing facilities (2025); US FDA, Modernization of Cosmetics Regulation Act of 2022 (2026).