Have a question? Call us: 
+1 (801) 290-7500
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Have a question? Call us: 
+1 (801) 290-7500
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Quality

Nelson Labs understands that supplier management can be a handful. To make things easier, we have taken the following steps to ensure that your on-site audit is as efficient as possible.

  • When you schedule your audit, a pre-audit information packet will be sent to help you prepare for the audit. The packet includes answers to basic questions about us (facility size, capabilities, employee totals, etc.) as well as essential regulatory information (copies of current certifications, change control policy, quality manual, etc.). By providing this information before the audit begins, you are able to spend your time auditing essential quality processes, instead of utilizing your resources gathering basic information about the company.
  • During your audit, you will have a qualified Nelson Labs regulatory specialist assisting you throughout your entire visit.
  • Each audit is tailored to your needs, ensuring that you accomplish your audit objectives while you are visiting us.
  • The majority of our audit documents are available electronically, which helps speed up the audit process. While perusing documents throughout the day, large HD monitors are provided to cut down on eyestrain.
  • We provide a catered lunch, so you do not have to leave the facility to get lunch.These are just a few extra benefits of partnering with Nelson Labs for your testing needs. If we can help make your audit better, we will!

Need to Schedule an Onsite Quality Audit?

If you would like to arrange an onsite audit, please email QualityAudits@nelsonlabs.com to schedule your visit.

Please keep in mind that we are currently hosting 2-3 client audits every week, so our schedule fills up quickly. Because of this, there may be a wait period before you can visit us onsite.

Need to Send Us a Supplier Questionnaire/Survey?

Because Nelson Laboratories, LLC. (NL) currently performs testing for thousands of companies, we are unable to complete individual quality surveys at this time. However, to assist in qualifying our company, we have created a packet of information that contains everything you should need.

If you would like to receive our audit packet, please email QualityAudits@nelsonlabs.com.

Certifications

Global Nelson Labs Headquarters in Salt Lake City, UT, USA

Nelson Labs facility in Salt Lake City, UT, USA is U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited.

Certifications Packet

Packet includes:

  • ISO 17025 Accreditation
  • ISO 17025 Accreditation Scope
  • FDA Registration (Device)
  • Generic Drug User Fee Act Amendment (Self Identification Validation Certificate)
  • FDA Registration (Drug)
  • GTP (Good Tissue Practice) Certificate
  • EU GMP Certificate of Compliance
  • EU GMP Certificate Scope
  • DEA Certificate
  • State of Utah, Department of Commerce Certificate
  • TGA GMP Certificate of Compliance

North American Laboratories Certifications

Itasca, IL, USA
Certification Packet
FDA: Establishment Registration and Listing for Homan Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Ontario, CA, USA
Certification Packet

Mexico City, Mexico
Certification Packet

Nelson Labs Europe Certifications

Nelson Labs Europe laboratory is:

  • GMP inspected and recognized by the Belgian Federal Agency for Medicinal and Healthcare Products (FAMHP)
  • GLP certified by Sciensano (ex-Scientific Institute of Public Health (WIV-ISP); Identification number: T02)
  • FDA registered (FDA Establishment Identifier (FEI): 3005742674)
  • ISO 17025 accredited by BELAC (Identification number: 363-TEST)
  • Agreement with CIR (crédit d’impôt de recherche), approved by the French authorities