FDA-registered 3PL facilities typically charge premium rates due to compliance requirements and specialized infrastructure. Storage fees range from $0.60-$1.20 per cubic foot/month, with temperature-controlled storage at $1.00-$2.00. Pick and pack fees run $3-$6 per order, with additional charges for lot tracking ($0.25-$0.50 per unit) and expiration date management. Many FDA-registered 3PLs require minimum monthly fees of $2,000-$5,000. Additional costs include quarterly audits, documentation fees, and specialized packaging requirements. Fulfill.com helps you find FDA-registered 3PLs that offer competitive pricing while maintaining strict compliance standards.
Leading FDA-registered 3PL hubs include Philadelphia/New Jersey (proximity to pharmaceutical companies), Southern California (import gateway), Chicago (central distribution), and Research Triangle, NC (biotech cluster). These regions have concentrations of FDA-compliant facilities with experienced staff familiar with cGMP requirements. Miami serves as a key hub for Latin American distribution, while Boston area facilities specialize in medical devices and biologics. The best location depends on your product type, temperature requirements, and target markets. Many FDA-regulated companies use multiple facilities to ensure supply chain redundancy.
FDA-registered 3PLs must maintain current FDA establishment registration, implement cGMP (current Good Manufacturing Practices) procedures, and provide detailed lot tracking and traceability. Essential capabilities include temperature mapping and monitoring, validated cold chain management, quarantine procedures, and recall management systems. They should conduct regular internal audits, maintain detailed SOPs (Standard Operating Procedures), and provide certificates of compliance. Look for facilities with experience handling your specific product category (drugs, devices, dietary supplements, cosmetics) as requirements vary. Third-party certifications like ISO 13485 or Safe Quality Food (SQF) indicate additional quality commitments.
The FDA Food Safety Modernization Act (FSMA) significantly impacts 3PL operations handling food, dietary supplements, and cosmetics. Key requirements include preventive controls, supply chain verification, sanitary transportation, and the Foreign Supplier Verification Program (FSVP) for imports. 3PLs must maintain Hazard Analysis and Risk-Based Preventive Controls (HARPC) plans, conduct environmental monitoring, and ensure proper allergen controls. They need qualified individuals (PCQI) overseeing food safety plans and must provide complete documentation for FDA inspections. Non-compliance can result in warning letters, import alerts, or facility shutdown, making proper 3PL selection critical.
FDA-registered 3PLs use validated shipping methods to maintain product integrity and compliance. This includes qualified shippers for temperature-sensitive products, validated packaging for 24-96 hour transit times, and continuous temperature monitoring devices. They work with specialized carriers experienced in pharmaceutical and medical device transport. Documentation includes chain of custody forms, temperature logs, and certificates of analysis. For controlled substances, additional DEA requirements apply. International shipping requires expertise in country-specific regulations and proper export documentation. Many FDA 3PLs offer white-glove delivery services for high-value medical equipment.
