FDA Registered · Reg. No. 3018077536

Regulatory & Compliance

Built for Regulated Healthcare, Diagnostics, and Life Sciences

Supera Fulfillment operates at the intersection of logistics, laboratory operations, and regulated healthcare supply chains. Our infrastructure, processes, and quality systems are designed to meet the stringent requirements of clinical laboratories, diagnostic manufacturers, biotechnology companies, and medical device organizations.

When patient samples, diagnostic kits, and regulated materials are involved, compliance is foundational.

FDA Registered Device Establishment

Supera Fulfillment LLC is registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment.

FDA Registration Number

3018077536

Our registration covers activities including:

  • Storage of medical devices and diagnostic kits
  • Repackaging and relabeling operations
  • Specimen collection kit assembly and distribution
  • Handling of non-sterile device components and mailers

Verify Registration

Registration can be verified in the FDA Establishment Registration & Device Listing database:

If the direct search link ever fails, users can search by facility name: “Supera Fulfillment LLC”

Note: FDA registration does not imply endorsement or approval by the agency.

ISO 13485 Quality Management System

Supera operates under an ISO 13485-aligned quality framework tailored for medical device and in vitro diagnostic (IVD) supply chains.

Our quality system includes:

  • Documented standard operating procedures
  • Change control and deviation management
  • Lot traceability and component tracking
  • Supplier qualification and monitoring
  • Risk-based process controls
  • Corrective and preventive action (CAPA) processes

Cleanroom Assembly & Controlled Environments

Medical and diagnostic kits are assembled in controlled environments designed to minimize contamination risk and ensure product integrity.

Capabilities include:

  • ISO Class 7 cleanroom kit assembly
  • Controlled material flow and gowning procedures
  • Environmental monitoring protocols
  • Segregated production workflows

Traceability & Chain of Custody

Supera maintains end-to-end traceability across inbound materials, kit assembly, storage, and outbound distribution.

Our systems enable:

  • Component-level traceability
  • Lot and batch tracking
  • Serialized kit tracking where required
  • Chain-of-custody documentation
  • Audit-ready reporting

Clinical & Diagnostic Logistics Expertise

Supera specializes in fulfillment operations for regulated healthcare programs, including:

  • At-home diagnostic collection kits
  • Clinical trial kitting
  • Specimen transport materials
  • Temperature-sensitive components
  • Laboratory consumables
  • Patient-centric logistics programs

Partnering With Regulated Organizations

Supera works with:

  • Clinical laboratories
  • Diagnostic manufacturers
  • Genomics companies
  • Medical device firms
  • Biotech organizations
  • Healthcare providers
Our goal is to function as a compliant extension of our clients’ operations — not just a logistics vendor.

Contact Our Compliance Team

For regulatory documentation, quality agreements, or audit inquiries: