FDA-Compliant Import & Controlled Distribution
Our Florida-based importation and distribution hub serves as the central node in Origin API's verified supply chain — handling customs clearance, FDA compliance, controlled storage, and distribution preparation for every API ingredient.
From Port of Entry to Distribution
Every step of our importation and distribution process is documented, verified, and compliant with FDA and USP standards.
Customs Clearance
All inbound API shipments undergo full customs clearance with proper HS tariff classification, commercial invoices, and country-of-origin documentation. Our logistics partners ensure smooth processing at U.S. ports of entry.
FDA Import Compliance
Every shipment is screened against FDA import requirements including Prior Notice filing, Drug Master File (DMF) verification, and compliance with 21 CFR import regulations for pharmaceutical ingredients.
Chain-of-Custody Initiation
Upon arrival at our Florida hub, each shipment enters our digital chain-of-custody system. Every handoff, temperature reading, and storage location is logged with timestamps and responsible personnel.
Intake & Batch Logging
Each batch is assigned a unique internal lot number, cross-referenced with the manufacturer's batch record. Physical inspection verifies packaging integrity, labeling accuracy, and quantity against shipping documents.
Controlled Environment Storage
Our Florida facility maintains USP-compliant storage conditions with 24/7 temperature and humidity monitoring, security systems, and segregated storage zones for different ingredient categories.
Sample Allocation & Distribution Prep
Samples are allocated from each batch for third-party testing by APICOA. Once verified, batches are prepared for distribution with complete documentation packages including COA, chain-of-custody records, and handling instructions.
Florida Distribution Hub Capabilities
Purpose-built for pharmaceutical-grade API storage and distribution with full environmental controls.
Climate-Controlled Storage
USP-compliant temperature zones (2-8°C cold storage, 15-25°C ambient, 25-30°C controlled room) with redundant monitoring systems.
Security & Access Control
24/7 surveillance, biometric access control, restricted zones, and complete visitor logging for pharmaceutical-grade security.
Deviation Management
Real-time alerts for temperature excursions, humidity deviations, or security events with automated escalation protocols.
Inventory Management
FIFO/FEFO inventory rotation, real-time stock levels, automated reorder triggers, and lot-level traceability for every unit.
Documentation Hub
Centralized document management for batch records, import filings, COAs, chain-of-custody logs, and distribution records.
Distribution Readiness
Temperature-controlled packaging, carrier qualification, and real-time shipment tracking for outbound distribution.
See Our Import & Distribution Process in Action
Schedule a walkthrough of our Florida distribution hub and learn how we maintain pharmaceutical-grade standards at every step.