Supplement co-packer for powders: run under 21 CFR 111, sized for small brands.
We blend and pack powdered dietary supplements under FDA's supplement cGMP rule, 21 CFR Part 111. That means a master manufacturing record you approve, identity testing on every dietary ingredient lot we blend, and a QC sign-off on every batch before it ships.
Quick answer: North Lakes Copacking blends and packs powdered dietary supplements under 21 CFR 111. You approve a master manufacturing record (MMR) with your specs. We identity-test every lot of every dietary ingredient we blend (lab price, about $80–$700 per lot), test finished batches to your MMR, keep reserve samples, and QC releases each batch. Runs start at 1,000 units.
What does 21 CFR 111 require from a supplement co-packer?
Part 111 is FDA's current good manufacturing practice rule for dietary supplements. For a powder co-packer, the parts that matter most are:
| Requirement | How we meet it |
|---|---|
| Master manufacturing record (§111.205) | One MMR per product: formula, specs, fill target and limits, tests. You approve it before the first run. |
| Identity testing (§111.75(a)(1)) | Every lot of every dietary ingredient we blend. A supplier COA alone doesn't count. |
| COA verification (§111.75(a)(2)) | First lot from each supplier, then yearly. |
| Finished batch testing (§111.75(c)) | Every batch, per the tests in your MMR. |
| Batch records | A batch production record for every lot, reviewed by QC. |
| Quality control release | QC releases components and finished batches. Nothing ships unreleased. |
| Reserve samples (§111.83) | At least twice the quantity needed for testing, kept 1 year past shelf life or 2 years from distribution. |
| Records | Kept 1 year past shelf life or 2 years from distribution. |
The regulation itself is at 21 CFR Part 111 on eCFR.
What does supplement setup cost, and why?
$500 for a new supplement formula, and $150 for each added flavor. FDA’s supplement rule (21 CFR 111) requires us to build a master manufacturing record, review your specifications and approve your suppliers before we make anything. Each flavor is its own formula with its own record, but most of the work carries over, so added flavors cost less. Identity testing is billed separately at the lab’s price.
Who is responsible for what?
You own the formula, label claims, overages, shelf life and stability, and adverse event reporting. We own making the product to your MMR and releasing it against your specs. When a customer complaint comes to us, QC reviews it and tells you within 1 business day.
What does identity testing cost?
The lab’s price plus shipping, with no markup: at the labs we use, about $80–$700 per dietary ingredient lot, depending on the method each ingredient needs. We confirm it on your quote. If you send us a finished blend that we only fill and pack, identity testing of ingredients doesn't apply; we need your blend spec. More in our identity testing guide.
What supplement powders do you run?
Protein, collagen, creatine, electrolytes, greens, pre-workout, sleep and focus blends, and other dry powder supplements in sachets, pouches and, from December 2026, stick packs. Low-dose actives are premixed before blending, and blend uniformity is tested on the first batch and after any change. See powder blending.
Are you GMP certified?
Part 111 doesn't require third-party GMP certification, and we don't claim one. We run to Part 111 and the SQF Fundamentals code, keep the records to prove it, and invite you to audit us. Our quality page covers what we'll show you.
Frequently asked questions
Do you need identity testing if I send a finished blend?
No. If we only fill and pack your pre-blended product, we do a visual and document check against your blend spec instead.
Who files adverse event reports?
The brand owner. We forward any complaint to you within 1 business day after QC review.
Can I audit your facility?
Yes. You can review our full SOPs on site. We send a document index and our FDA registration confirmation on request.
How long does a first supplement run take?
Standard turnaround is 30 days from a signed quote. First supplement runs need time for the MMR, specs and ingredient testing, so plan 4–5 weeks.
Related reading
- Supplement Ingredient Identity Testing — What Actually Needs to Be Tested
- What Is a Certificate of Analysis?
- Why Your Supplement Ingredients Will Sit in Quarantine (And How to Prevent It)
- How to Determine Shelf Life for a Powder Supplement
Tell us about your run.
Pricing from $2,750 flat. FDA registered. You talk to the owner.
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