Outsourcing logistics and supply chain tasks to a third-party provider or 3PL have become more common. Outsourced operations typically include a mix of shipping, storing, packing and/or delivering of goods—raw materials to the finished product.
We ranked the best 3PLs using real customer reviews, service quality, and industry expertise. Our team analyzes each provider’s pricing, fulfillment speed, accuracy, and warehouse locations to match businesses with top-performing 3PLs. Only the most reliable, efficient, and well-rated providers make our list.
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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.
Temperature control is critical for FDA-regulated products, with many requiring strict 2-8°C (refrigerated) or -20°C (frozen) storage. FDA-registered 3PLs must have validated temperature mapping, 24/7 monitoring systems with alerts, backup power systems, and detailed SOPs for temperature excursions. They should provide continuous data logging, regular calibration certificates, and maintain at least 2 years of temperature records. For biologics and vaccines, even brief temperature excursions can destroy product efficacy. Advanced facilities offer multiple temperature zones, cryogenic storage capabilities, and validated thermal packaging for shipments.
FDA-registered facilities require stringent security including restricted access controls, 24/7 surveillance systems, and detailed visitor logs. For controlled substances, DEA requirements include cage storage, dual-custody procedures, and enhanced background checks. Cybersecurity is equally important with requirements for data encryption, audit trails, and protection of proprietary formulas or patient information. Many facilities maintain C-TPAT certification for supply chain security. Look for 3PLs with documented security procedures, regular security audits, and incident response plans. Proper security prevents theft, counterfeiting, and maintains product integrity throughout the supply chain.
Fulfill.com specializes in connecting businesses with FDA-registered 3PLs that match their specific regulatory requirements. We verify current FDA registrations, audit compliance histories, and evaluate facilities based on their experience with your product type. Our platform considers critical factors like temperature capabilities, quality certifications, and geographic coverage. We help you avoid non-compliant providers that could jeopardize your FDA status. Whether you need cGMP-compliant warehousing for pharmaceuticals, medical device storage with ISO 13485, or FSMA-compliant food handling, we identify the top 3PLs with proven track records in FDA-regulated logistics.
