Food & supplement manufacturing · 21 CFR 111 / 117 · Georgia Dept. of Agriculture
Between your facility and its first inspection, one accountable partner.
Ten30 Solutions builds the compliance system that gets a food or supplement production facility ready for FDA and Georgia inspection, the first time. The person who reads your regulations has also serviced the machines on your floor.
Every stage is a control point.
From receiving to release, each step in your process is a place an inspector looks, and a record we build to prove it.
Receiving
Weigh & dispense
Blending
Encapsulation & fill
Package & label
QC & release
The line and the file are one system. We build the record behind every stage, so when the inspector follows your process, the paper is already there to meet them.
The difference
One accountable partner, not five vendors.
Most facilities end up managing a compliance consultant, a trainer, and an equipment technician who never speak to each other, and paying for the gaps between them. Ten30 puts all three in one place.
The compliance file
Product classification, the documentation system, SOPs, and a mock inspection, built to the standard your product actually falls under: 21 CFR Part 111 or 117, and Georgia Department of Agriculture licensing.
The production line
A former field-service technician on LFA production equipment, including the SACF 25 capsule-filling platform. The person who knows your compliance file also knows your machines.
One accountable partner
The regulatory system, the operator training, and the equipment support under a single engagement, so nothing falls into the space between vendors who never talk.
How the engagement works
Readiness first. Everything else as you choose.
A phased engagement built around your facility and your products. You get inspection readiness first, then add training, equipment support, and sourcing only when you want them.
Compliance & inspection readiness
The complete system that carries you from a bare facility to a documented, inspection-ready operation, timed so the onsite visit happens when you are genuinely ready.
- Classification of every product, so labeling and claims sit on the right side of the line
- Evidence-based readiness assessment with a written gap report and corrective plan
- The documentation system: specifications, supplier qualification, master & batch records
- Core SOPs and a Food Safety Plan where it applies
- Label and marketing-claims screening for classification and readiness
- Direct coordination with your FDA agent and the Georgia Department of Agriculture
- One onsite mock inspection before the real one, with a corrective close-out
- Certified specialists brought in for deep documentation, disclosed and approved first
Facility setup optimization
Layout, workflow, and implementation advisory drawn straight from the readiness findings.
Onsite training
GMP, sanitation, correct operation, and batch documentation, taught to your team on the floor.
Technical oversight & equipment support
Setup, troubleshooting, and maintenance of your capsule filler and other equipment, with on-call support.
Supply sourcing
Capsules, packaging, and GMP supplies from vetted suppliers, on your written go-ahead.
What the inspector opens first
Inspections are lost on paper, not brick.
Most first inspections do not fail on the building. They fail on the documentation behind it, the records that show the operation is controlled, repeatable, and safe.
That file is the heart of what we build, in place and defensible before an inspector ever walks the floor.
- 01Product specificationsFinished-product and component identity, purity, strength
- 02Supplier qualificationApproved suppliers, certificates of analysis, verification
- 03Master & batch recordsManufacturing instructions and the proof each batch followed them
- 04Core SOPsSanitation, pest control, hygiene, complaints, recall
- 05Food Safety PlanWhere preventive controls apply to the operation
- 06Corrective-action logHow deviations are caught, closed, and prevented
Why one partner
The person who reads your regulations has serviced your machines.
Ten30 connects the regulatory requirements, the production workflow, the operating records, and the equipment itself under one accountable engagement. We start by confirming how each product is classified, because these are foods and supplements, not drugs, and keeping your labeling and claims on the right side of that line is what protects the business you have already built.
Ten30 Solutions provides compliance systems, training, and advisory support. Where the work calls for a licensed attorney, a Preventive Controls Qualified Individual, or a laboratory, we bring in the right certified specialist and tell you before any cost is incurred. Final licensing and inspection decisions rest with the authorities; our job is to make you as ready as disciplined preparation allows.
- CFR21 CFR Part 111 & 117Dietary-supplement and preventive-controls requirements, matched to how each product is classified.
- GA-DOAGeorgia Dept. of AgricultureFacility licensing, pre-inspection expectations, and the pathway for your product mix.
- EQLFA production equipmentHands-on field service, including the SACF 25 capsule-filling platform on your floor.
Let's talk about your facility
Tell me where you are. I'll tell you what it takes to be ready.
Planning, mid-build, or getting ready for inspection, the first conversation is a straight read on what your facility needs and how we would get there together.
or write directly · admin@ten30studio.com