Materials documented.
Process controlled.
FDA ready.
FDA compliance for medical and food products requires specific materials, documentation, and process controls. Design for compliance from the start — retrofitting is expensive.
Key principles.
From mill heat
EN 10204 3.1 certificate at minimum. 3.2 (witnessed) for highest tier. Heat number traceable.
21 CFR 177
316L stainless, FDA-compliant plastics (PEEK, silicone, PTFE, HDPE). Verify per specific FDA section.
Sanitary cleanable
Ra 0.8 µm general food, Ra 0.4 µm dairy/pharmaceutical. Electropolished for biopharm.
3-A standard
Sloped surfaces drain cleaning fluid. No horizontal traps.
Sanitary
Welds ground smooth. Orbital TIG for sanitary tube welds with full purging.
No crevices
Avoid crevices where bacteria grow. Sealed gaps with food-grade gaskets.
FAQ
What FDA section applies?
Depends on application: 21 CFR 175 (adhesives), 177 (food contact materials), 178 (additives), 800 (medical devices). Verify per product.
Compliance vs registration?
We comply with FDA materials requirements. Customer holds product registration with FDA. We support customer's compliance.
Audit trail required?
Yes. Material lot traceability, processing records, inspection records. Retained per industry requirements.
Coatings and platings?
Most coatings are NOT FDA compliant for direct food contact. Use uncoated 316L or compliant coatings. Verify before specifying.
GMP requirements?
GMP (Good Manufacturing Practice) for pharma. We support customer's GMP system; we are not GMP-registered ourselves.
Documentation for FDA submission?
Customer compiles FDA submission. We provide: material certs, processing records, dimensional inspection, testing results.
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