PPE Manufacturing / Medical Distribution
How PuraVita Medical Maintains FDA and ASTM Traceability Across Every Shipment
Medical-Grade Distribution for American-Made PPE
PuraVita Medical manufactures ASTM Level 3 surgical masks and other personal protective equipment at their production facility in the United States. As an FDA-registered manufacturer, PuraVita requires complete traceability on every unit — from raw material lot through production, warehousing, and final delivery to hospitals, clinics, and distributors.
The distribution challenge extends beyond standard fulfillment: every shipment must carry accurate lot documentation, meet FDA 21 CFR Part 820 quality system requirements, and arrive at healthcare facilities with full chain-of-custody records. PuraVita's customers include hospitals that audit their suppliers' logistics processes as part of vendor qualification.
Founders 3PL serves as PuraVita Medical's distribution partner, managing finished goods warehousing, lot-tracked inventory, and compliant shipment documentation from an FDA-registered facility.
FDA-Compliant Warehousing
PuraVita Medical's products require warehousing in an FDA-registered facility that maintains quality system documentation per 21 CFR Part 820. This means controlled storage conditions, documented receiving procedures, and traceable handling processes — requirements that eliminate most standard 3PL warehouses.
Founders 3PL's facility is FDA-registered and operates under ISO 13485 quality management protocols. PuraVita's finished goods are received, inspected, stored, and shipped under documented procedures that satisfy both FDA requirements and the vendor audits conducted by PuraVita's hospital customers.
Lot-Level Traceability
Every box of PuraVita masks carries a lot number tied to a specific production run, raw material batch, and quality release record. If a quality issue surfaces, PuraVita must be able to identify every unit from that lot — where it's stored, where it shipped, and who received it.
Founders 3PL tracks PuraVita's inventory at the lot level from receiving through shipment. Every outbound order includes lot documentation, and the inventory system maintains a complete chain-of-custody record. In the event of a recall or quality investigation, PuraVita can trace any unit to its current location within hours.
ASTM-Compliant Documentation
PuraVita's ASTM Level 3 surgical masks are classified as medical devices, and shipments to healthcare facilities must include certificates of conformity, lot-specific test reports, and compliant labeling. Missing or incorrect documentation can delay receiving at hospitals and trigger vendor compliance findings.
Founders 3PL includes all required documentation with every PuraVita shipment — printed and verified against the lot records in the inventory system. The documentation workflow is built into the shipping process, not added as an afterthought, ensuring that every package arrives with the paperwork healthcare facilities require.
Distribution Network Management
PuraVita ships to a diverse customer base — large hospital systems ordering pallets, small clinics ordering cases, and distributors ordering mixed lots. Each customer type has different shipping requirements, receiving procedures, and documentation expectations.
Founders 3PL manages PuraVita's multi-channel distribution from a single facility. Pallet shipments to hospital DCs go via LTL with advance ship notices. Case shipments to clinics go via parcel with lot certificates. Distributor orders follow custom routing requirements. All channels operate under the same cost-plus pricing model with full lot traceability.
Our masks go into operating rooms. The logistics chain has to meet the same standards as the manufacturing process. Founders 3PL operates from an FDA-registered facility with the documentation discipline our hospital customers require.
PuraVita Medical Team