Our lead practice
GMP & manufacturing compliance.
We help food and supplement manufacturers prepare their facilities, documentation, and operating systems for the applicable FDA and state inspections. The engagement begins with classification and readiness, then expands into implementation, training, and equipment support as you choose.
Compliance & inspection readiness
A coordinated system that carries your current operation toward documented inspection readiness, 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 registration agent and the applicable state or local regulatory authority
- One onsite mock inspection before the real one, with a corrective close-out
- Qualified specialists engaged where the scope requires, their role and cost 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 production equipment, with on-call support.
Supply sourcing
Packaging and GMP supplies from vetted suppliers, on your written go-ahead.
What the inspector opens first
Documentation is where readiness is won or lost.
Missing or incomplete documentation is a common source of preventable inspection findings, 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
Bring us the problem
Getting a facility ready for inspection?
Planning, mid-build, or close to inspection, the first conversation is a straight read on what your facility needs and how we would get there.