Why “FDA-Registered 3PLs” Matter — And How Jay Group Leads the Way

In regulated industries—supplements, medical devices, cosmetics, specialized foods—knowing that your 3PL is FDA-registered  3PLs and cGMP-compliant 3Pls are not optional. It’s essential. This article explains what it means to be an FDA-registered 3PL, why it matters for your brand, and how Jay Group’s dual-coast, regulated-capable facilities give you both compliance and competitive advantage.

What Does “FDA-Registered 3PL” Mean?

An FDA-registered 3PL is a logistics provider formally registered with the U.S. Food and Drug Administration. Registration indicates that the facility handles products in regulated categories under conditions that the FDA monitors or inspects.

(Reference: FDA — Drug Supply Chain Security Act (DSCSA) .gov)

Key implications:

• Facilities must follow quality systems and documented SOPs to maintain compliance.

• They support lot, expiration, and traceability controls (important in recalls).

• They must handle quarantine, inspections, recall execution, and secure storage in ways that meet regulatory expectations.

At Jay Group, we go further: we operate cGMP-compliant processes alongside FDA registration, allowing us to handle high-risk product categories with rigor and care.

Jay Group’s Regulated Capabilities & Infrastructure

Jay Group isn’t just “FDA-registered” in name — we build systems to support regulated brands at scale.

Dual-Coast FDA-Registered Facilities

We have U.S. fulfillment centers in Lancaster/Mountville, Pennsylvania (East Coast) and Reno, Nevada (West Coast), all FDA-registered and climate controlled.

• Lancaster: flagship ~250,000 sq ft, 7-day operations, climate zones, advanced contract packaging

• Mountville (PA): ~140,000 sq ft, mixed climate, flexible fulfillment operations

• Reno: ~130,000 sq ft, proximity to West Coast markets, rapid transit to CA, OR, NV regions

Each site carries ISO/IEC 27001 certification for data security, and they run sustainable power (100% renewable energy) and other green infrastructure features.

Quality & Compliance Services

To serve regulated clients, Jay Group provides:

• Quarantine & secure holding of suspect inventory

• Lot / expiry tracking via Manhattan WMS, with FEFO / FIFO logic

• Inspection & sampling protocols (visual and manual)

• Recall support & traceability — systems to isolate and track goods

• Secure temperature- and humidity-controlled zones

• Full documentation and SOPs consistent with cGMP expectations

(For context: U.S. Code of Federal Regulations — 21 CFR Part 210–211 .gov)

Why Working with an FDA-Registered 3PL Matters For Your Brand

1. Regulatory compliance assurance
   Using an FDA-registered partner helps protect your brand from FDA audit risk, compliance gaps, or supply chain liability.

2. Seamless traceability & recall readiness
   Lot-level tracking, quarantine, and tested recall protocols mean issues are contained fast—with less disruption.

3. Access to regulated categories
   A true FDA-registered 3PL can support dietary supplements, cosmetics, medical devices, personal care, specialty food streams. Brands in these verticals require it.

4. Reduced friction in inspections & audits
   If your products are FDA-regulated, using compliant 3PL facilities means inspectors have expectations met — fewer surprises, smoother audits.

5. Confidence in quality & handling
   Regulated partners must maintain documented systems, environmental controls, and consistency. That safeguards sensitive SKUs.

(Reference: Johns Hopkins Bloomberg School of Public Health — Supply Chain Transparency in Public Health .edu)

Jay Group in Practice: Use Cases & Proof Points

• Medical / Health Wearable (Evie Ring)
  Jay Group was selected as the 3PL for Movano Health’s Evie ring, a medical-grade health wearable under FDA review. Inventory and fulfillment are handled in Jay’s FDA-registered facilities.

• Beauty, supplements, personal care
  Many of Jay’s clients operate in regulated / semi-regulated verticals (cosmetics, supplements, hygiene). The service lines (CGMP, contract packaging, regulated storage) reflect that capability.

• Amazon prep + regulatory products
  Jay’s dual-coast nodes also act as Amazon prep centers, supporting regulated SKUs while preserving compliance workflows.

Best Practices When Selecting an FDA-Registered 3PL

When evaluating a 3PL claiming FDA registration, check for:

• Active FDA registration status and documents

• Evidence of cGMP processes / QMS systems

• Environmental controls (temperature, humidity)

• Lot / batch traceability and recall workflows

• Inspection, sampling, and quarantine procedures

• Integration between regulated and non-regulated SKUs (to avoid cross-contamination risk)

• Client references in regulated industry verticals

• Data security controls (ISO 27001, access management)

Jay Group delivers on all these fronts with documented systems, solid client track record, and transparent compliance operations.

Conclusion & Call to Action

If your brand competes in regulated products—whether supplements, cosmetics, medical devices, specialty food, or personal care—then choosing a truly FDA-registered, cGMP-capable 3PL is not optional. It’s part of your product integrity, compliance, and brand promise. Jay Group’s dual-coast, climate-controlled, ISO- and FDA-certified infrastructure, along with deep quality systems, gives you a partner built for regulated scale. Let’s talk.