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 to gather 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 [email protected] 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 waiting 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 [email protected].
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.
- ISO 17025 Accreditation
- ISO 17025 Scope of Accreditation
- FDA: Medical Device Establishment Registration
- FDA: Generic Drug Statement of Compliance (GDUFA)
- FDA: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- FDA: Drug Establishment Registration
- DEA: Control Substance Certification
- EMA EU GMP Memo
- Certificates of GMP Compliance of a Manufacturer – DMA
- EMA Report – Danish Medicines Agency
- Utah State Business License
- ISTA Testing Laboratory Certification
- Business License: City of Taylorsville
North American Laboratories Certifications & Qualifications
Bozeman, MT, USA
Fairfield, NJ, USA
Itasca, IL, USA
FDA: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Ontario, CA, USA
Mexico City, Mexico
Nelson Labs Europe Certifications
Nelson Labs Europe laboratory is:
- Certification Packet
- 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