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 an ISO 13485 certified quality system 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

Certifications you can verify

Both certifications below cover our Houston facility at 3240 Fuqua St, Suite 3246. Certificate numbers, scope and dates are published here so you can confirm them directly with the issuing body.

Quality Management SystemISO 13485:2016
Registrar
NSF International Strategic Registrations (NSF-ISR), Ann Arbor, MI
Certificate number
C0632412-MD2
Certified scope
Kitting, labeling, re-packaging, solution filling into vials, packaging, and capping and de-capping of vials and tubes intended for healthcare use.
Issued
April 25, 2025
Valid through
October 28, 2027
Verify at nsf-isr.org or by calling NSF-ISR at (888) NSF-9000.
Controlled Assembly EnvironmentISO Class 7 Cleanroom
Certifying firm
ENV Services, Inc., Hatfield, PA
Report control ID
228-370165-68903
Result
ISO Class 7 at 0.5 microns, Pass. Tested to ISO 14644 under an ISO 17025 accredited program.
HEPA filter integrity
Leakage at or below 0.01 percent, Pass
Airflow and pressure
28 air changes per hour, positive pressure to ambient
Last certified
February 6, 2026
Recertified on a scheduled interval. Current certification report available on request.
State Licensing

Texas Device Manufacturer License

Issuing authority
Texas Department of State Health Services, Regulatory Licensing Unit
Authorized activity
Device Manufacturer
Statutory basis
Texas Health and Safety Code Chapter 431, the Texas Food, Drug, Device and Cosmetic Act, and Title 25 of the Texas Administrative Code
Licensed address
3240 Fuqua St, Unit 3246, Houston, TX 77047. Site specific and non-transferable.
Expires
February 27, 2027
Renewal cycle
Renewed every two years

A Texas device manufacturer license authorizes manufacturing activity at the licensed address under state law. It is separate from the certifications above, and it is not an FDA clearance, approval or classification.

ISO 13485 certification describes our quality management system and the cleanroom classification describes our assembly environment. Neither is a clearance, approval or classification of any client device or test.

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:

Related reading

Practical guidance from our team on building and running kit programs.