Quality & manufacturing

Credentials, not claims.

Most supplement brands lean on stock badges. We'd rather tell you exactly what we do, the regulations, the test methods, and the documents we'll send you with every bottle.

FDA-registered facility

Our manufacturing facility is registered with the U.S. Food and Drug Administration under Section 415 of the Federal Food, Drug, and Cosmetic Act and renews biennially. FDA registration confirms the facility exists and is subject to inspection, it is not an FDA approval or endorsement of any product.

21 CFR Part 111 cGMP

We operate under Current Good Manufacturing Practice for dietary supplements as codified in 21 CFR Part 111. This includes written specifications for every raw material and finished product, identity testing of every incoming ingredient, calibrated equipment, trained personnel, and complete master and batch production records for every lot we produce.

Third-party testing, ISO 17025

Finished formulations are independently tested by an ISO/IEC 17025-accredited contract laboratory. Test panels include identity, potency against label claim, heavy metals (lead, arsenic, cadmium, mercury) per USP <232>/<233>, and microbial limits (total aerobic count, yeast and mold, Salmonella, E. coli).

Certificate of Analysis per bottle

Every bottle ships with a lot-specific Certificate of Analysis. The COA lists each active, the testing method used, the specification limit, the actual measured result, and the pass/fail status, alongside the testing laboratory's name and accreditation. Scan the QR code on your label to view it.

Pharmacist review

Before any bottle enters production, a U.S.-licensed clinical pharmacist reviews the requested formulation against published upper tolerable intake levels (NIH ODS), known nutrient–drug interactions, and any patient-disclosed contraindications. Nothing is weighed until the formulation is signed off.

Allergen-aware sourcing

Our capsules are plant-derived HPMC (hydroxypropyl methylcellulose). Formulations are produced free of the nine major food allergens by default, milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. We do not use gelatin, dyes, magnesium stearate, or titanium dioxide.

Made in the USA

All manufacturing happens at our facility in North Carolina. We source pharmaceutical-grade raw materials from vetted, US-based distributors and maintain a documented chain of custody from supplier to finished bottle.

Pharmaceutical-grade ingredients only

We use the highest available purity grades, USP, EP, or pharmaceutical grade where they exist. We never reformulate from finished consumer products and never use proprietary blends that hide individual doses.