Question 1

What is GMP?

Accepted Answer

Good Manufacturing Practice (GMP) is a system of documented processes, procedures, and controls that ensures a manufactured product is consistently produced to a defined quality standard. For dietary supplements in the United States, GMP is defined by the FDA in 21 CFR Part 111.

Question 2

What does 21 CFR Part 111 require?

Accepted Answer

21 CFR Part 111 is the FDA's binding regulation for dietary supplement manufacturing. It requires an independent Quality Control Unit, ingredient identity verification, written master manufacturing records, batch production records for every lot, equipment and facility qualification, and documented CAPA processes.

Question 3

What is a Certificate of Analysis (COA)?

Accepted Answer

A COA is a document, generated at the end of a production run, that lists the tested specifications of that finished lot — identity, potency, and contaminant results as appropriate. Every lot we manufacture has a COA on file.

Question 4

What is an NDI and when does it matter?

Accepted Answer

A New Dietary Ingredient (NDI) is a dietary ingredient not marketed in the U.S. before October 15, 1994. Under DSHEA, an NDI generally requires notification to the FDA before it can be sold. If your formula uses a novel ingredient, this is worth reviewing with regulatory counsel early.

Question 5

Capsule vs. tablet vs. powder — how do I choose?

Accepted Answer

Capsule: fastest to market, easy taste-masking, precise unit dose, good for herbal blends. Tablet: cost-efficient at scale, high dose density, coating tunes release. Powder: largest serving size, flavored beverage formats, protein/greens/hydration categories. If you're unsure, tell us the ingredient profile and we'll recommend a format.

Question 6

Do you manufacture softgels, gummies, or liquids?

Accepted Answer

No. We manufacture capsule, tablet, and powder only. If your formula requires a format outside our scope, submit a quote request anyway — we'll route you to a trusted partner.

Question 7

Can I use a stock formula, or do I have to bring my own?

Accepted Answer

Both are supported. Stock formulas are the fastest path to launch. Custom formulas require a specification sheet and, depending on the ingredients, an ingredient qualification step before the first run.

Question 8

What ingredient testing do you perform?

Accepted Answer

We test every incoming lot of raw materials for identity before it is released for use. Additional tests — potency, heavy metals, microbial — are selected based on the finished-good specification and the ingredient's risk profile.

Question 9

Where is the facility located?

Accepted Answer

Las Vegas, Nevada. Full address and hours are available on our contact page.

Plain-language answers.

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