Quality and food safety: what we do on the floor, and what we'll show you.
We're a small shop and we won't claim a certificate we don't hold. Here's what we actually run: written procedures, a batch record for every lot, tested ingredients, controlled air, and records you can audit.
Quick answer: North Lakes Copacking is an FDA-registered facility that runs dietary supplements under 21 CFR 111 and food under 21 CFR 117, following the SQF Food Safety Fundamentals code. SQF certification is in progress. Every lot has a batch record, ingredients are tested by risk, lab work is passed through at cost, and customers can review our SOPs on site.
What standards do you run to?
| Standard | Status |
|---|---|
| FDA food facility registration | Registered; confirmation sent on request |
| 21 CFR 111, dietary supplement cGMP | Followed for all supplement work |
| 21 CFR 117, food cGMP and preventive controls | Followed for all food work |
| SQF Food Safety Fundamentals, Intermediate | Our framework; certification in progress |
| Product liability insurance | Active; documentation on request |
What happens on the floor?
- Clean air. HEPA air scrubbers run 24/7, and dust is captured at the source with HEPA vacuums.
- Humidity control. We target under 40% relative humidity in the production zone and log it twice a day.
- Clean lines. ATP swabs before every run; allergen swabs after allergen clean-outs.
- One allergen profile at a time in production.
- Calibrated scales, verified daily with certified, NIST-traceable test weights.
- Lot and date code on every pack, tied to the batch record.
- Fill weights checked and recorded every run under our net contents policy.
How are ingredients controlled?
Every incoming lot is received against a spec and held until released. Higher-risk food ingredients are Salmonella-tested and held until results clear. Supplement ingredients we blend are identity-tested lot by lot under 21 CFR 111.75. See supplement co-packing and why ingredients get quarantined.
What documents can I see?
- Our QMS document index, with every SOP and form by title and scope.
- Our FDA registration confirmation.
- A draft quality agreement.
- Full SOPs, on site during an audit or visit.
- Batch records and fill-weight records for your runs.
If something goes wrong
If a run misses spec because of our error, we own it and make it right, directly with you. A batch that fails QC isn't quietly reworked; it's investigated, documented and redone, and you hear exactly what happened.
Frequently asked questions
Are you SQF certified?
Not yet. We run to the SQF Food Safety Fundamentals code and certification is in progress. We won't claim it until we hold it.
Are you GMP certified?
There's no government GMP certificate. Third-party GMP certification isn't required by 21 CFR 111. We run to the regulations and you can audit us.
Will you sign an NDA?
Yes, before any formula details change hands.
Can I visit?
Yes. Ask for a walkthrough any time.
Related reading
- FDA Registered Co-Packers — What It Means
- Why Your Supplement Ingredients Will Sit in Quarantine (And How to Prevent It)
- What Is a Certificate of Analysis?
- The Questions to Ask a Co-Packer Before You Sign Anything
Tell us about your run.
Pricing from $2,750 flat. FDA registered. You talk to the owner.
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