FDA Regulated Fulfillment: What Retail Brands Need to Know

If your DTC brand sells FDA-regulated products, fulfillment isn’t just about getting orders out the door. It’s about staying compliant, protecting product integrity, and keeping your supply chain audit-ready. FDA regulations shape everything from warehouse processes to how a 3PL handles receiving, storage, kitting, and final shipping. Choosing a partner like All Points — especially one based in Atlanta with the benefit of fast national reach — gives you the structure and visibility you need to ship confidently and consistently.

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What FDA Regulated Fulfillment Includes

Any fulfillment center storing or shipping regulated goods must be registered with the U.S. Food and Drug Administration and maintain up-to-date permits at the state or county level. That registration must reflect the exact categories of products they handle. This matters because FDA oversight covers a wide range of retail items: everything from supplements and foods to cosmetics covered under MoCRA, medical devices, OTC drugs, and other regulated personal care products.

For ecommerce brands using a 3PL or even Amazon FBA, compliance still starts with you. Fulfillment partners must be vetted for valid FDA registration, the right product categories, and documented handling procedures. Brands that skip this step run the risk of recalls, regulatory notices, or major disruptions if inventory is stored in the wrong type of facility.

How the Workflow Actually Operates in a Compliant Environment

FDA regulated fulfillment begins with product classification. Every SKU needs to be correctly categorized — supplement, cosmetic, device, OTC drug — and matched to its specific storage, labeling, and traceability requirements. Once a 3PL confirms those categories, they must validate their own registration and permits align with your product mix and share their SOPs for temperature control, quarantined inventory, lot capture, and recalls.

Onboarding is one of the most important steps. This is where brands and 3PLs align on temperature monitoring, QC checkpoints, rejection handling, and the exact way work-in-progress items are traced. As products arrive, the receiving team works from advance shipping notices, checking each shipment for label accuracy, damages, and required documentation. Lot and batch information gets captured immediately. Strong operators move inbound inventory to “dock-to-stock” within 24 hours to reduce exposure risk and bring items into active inventory quickly.

Once products are stored, traceability becomes the heart of the process. Every touch — receiving, storage, picking, kitting, and final shipping — must be barcode-scanned. Inventory is allocated using FIFO or FEFO rules, depending on the needs of your product. Accuracy must remain exceptionally high, and cycle counts should occur frequently to maintain that standard.

Kitting and printing carry their own compliance steps. Any kit that includes regulated goods must follow a pre-approved bill of materials and detailed work instructions. Inserts, regulatory labels, safety information, and documentation must be placed with precision. A 3PL with integrated on-site printing reduces the potential for mistakes and keeps turnaround times tight.

Behind the scenes, internal audits and mock recalls help confirm traceability systems work the way they should. Any time product categories or volumes change, the fulfillment provider must update their registration and permit filings. As orders ship, the same discipline applies: scan-verified accuracy, correct documentation in each shipment, and carrier selections that protect freshness and delivery timing.

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Understanding KPIs and SLAs for Regulated Goods

FDA-regulated fulfillment relies on more rigorous performance standards than standard DTC logistics. Inventory accuracy needs to stay above 99.5%, pick accuracy should be above 99.8%, and dock-to-stock should remain within a 24-hour window. Lot and batch capture must always be at 100% compliance. These metrics safeguard both customer experience and your regulatory posture, ensuring that every order leaves the warehouse in a fully traceable, audit-ready state.

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What Drives the Cost of FDA Regulated Fulfillment

The cost structure changes once regulated goods enter the picture. Compliance management adds administrative overhead, and warehouses must invest in precise recordkeeping, environmental monitoring, and regular audits. Labor hours rise because inbound inspections, batch capture, and quality checks require more time and skill.

Storage conditions may also increase costs, especially if products need temperature-controlled zones or secure, segregated storage. Custom packaging and kitting steps — including regulatory inserts and additional labeling — also influence the final fulfillment price. Product complexity plays a role as well; brands with high SKU counts, short-dated products, or multiple overlapping batches tend to see higher handling times.

Location matters too. Using Atlanta as your fulfillment base reduces shipping zones and transit times for most of the U.S., helping offset some of the additional compliance-related expenses.

Risks and How a Strong Operator Manages Them

The biggest risk for any brand is storing products in a facility that isn’t properly registered or permitted. That alone can trigger compliance issues, warning letters, or even recalls. A strong 3PL eliminates this risk through transparent documentation, up-to-date registration, and SOPs you can audit.

Accuracy in lot and batch tracking is another critical point. Incomplete traceability makes recalls slow and costly, and can damage consumer trust. That’s why scan-based systems and regular mock recalls are essential.

Temperature excursions, improper labeling, and missing inserts also carry compliance consequences. Operators that integrate temperature monitoring, strict relabeling controls, and in-house printing minimize errors and downstream risks. SLA failures — such as late shipments or delayed inbound processing — can further compromise product integrity, especially for short-dated goods. Atlanta-based distribution helps reduce those delays thanks to its two-day ground reach.

Why Atlanta Gives Regulated Brands an Edge

For FDA-regulated products, geography plays a direct role in compliance and customer satisfaction. Atlanta sits within a two-day ground radius of roughly 80% of U.S. households, which helps preserve product freshness and reduce shipping costs. Its airport, rail terminals, and interstate network offer consistency that other regions can’t match, especially during peak seasons or weather-related disruptions.

The Atlanta market also has a deep pool of logistics talent familiar with regulated goods. For Southeastern brands, the proximity to co-packers and suppliers shortens inbound lead times and reduces handoff risks across the supply chain.

What You Can Expect from All Points

Working with All Points means you’re partnering with a 3PL that treats FDA compliance as an everyday operating standard. Our team manages the entire flow — inbound receiving, lot capture, storage, pick and pack, kitting, and returns — with operator-grade SOPs built for regulated goods. We use scan-verified lot tracking, tight dock-to-stock cycles, multiple QA checkpoints, and transparent reporting so you always know where your inventory stands.

Our integrated kitting and printing capabilities allow us to build compliant kits, relabel items, and apply required inserts without relying on outside vendors. And our Atlanta location gives your brand the speed, reach, and cost-efficient parcel network needed to serve customers across the country.

Since 1995, All Points has combined disciplined fulfillment operations with the service mentality of a family-owned business, supporting retail brands from emerging startups to global names.

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FAQs

What is FDA regulated fulfillment?
It’s the process of storing and shipping regulated goods in a facility registered with the FDA and equipped with documented controls for tracking, handling, labeling, and recalls.

How can I confirm a 3PL’s FDA registration?
Request their registration number, the categories covered, renewal dates, state and county permits, and their SOP documentation.

Do regulated products require different SLAs?
Yes. Lot capture, accuracy rates, traceability, and dock-to-stock timelines all follow stricter performance standards.

Are costs higher for regulated inventory?
They can be, due to increased inspections, documentation, storage requirements, and specialized QA workflows.

How does Atlanta improve fulfillment for regulated goods?
Its central location reduces shipping costs, speeds up delivery, and gives access to reliable air, rail, and highway infrastructure.

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