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Nelson Labs — Salt Lake City

Salt Lake City, Utah, United States · Testing lab

This is a record of what regulators published, not a rating.

Site facts

Company
Nelson Labs
Name(s) in FDA data
Nelson Laboratories, LLC
FEI number(s)
3000233845 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Salt Lake City, Utah, United States 84123
Records matched
12 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
30 Jul 2025 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …O 17025 accredited facility. The five-building campus offers over 800 microbiological and analytical laboratory tests. Testing Services Biocompatibility & Toxicology Clinical Reprocessing Valida…
  • Microbiology
    …A) registered and ISO 17025 accredited facility. The five-building campus offers over 800 microbiological and analytical laboratory tests. Testing Services Biocompatibility & Toxicology Clini…
  • Extractables & leachables
    …y tests. Testing Services Biocompatibility & Toxicology Clinical Reprocessing Validations Extractables & Leachables Facility & Process Validations Method Development Packaging Solutions Protec…

Taken from the company's web page for this site. Source: https://www.nelsonlabs.com/locations/salt-lake-city-ut/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 30 Jul 2025
    Form 483 observations 11 posted Form 483 citation(s)

    Citation summaries (11)
    • 21 CFR 1271.160(b)(4): Training of personnel
    • 21 CFR 1271.160(b)(5): Monitoring systems
    • 21 CFR 1271.180(a): Design adequate to bar spread of CD's
    • 21 CFR 1271.195(a): Adequate control, proper conditions
    • 21 CFR 1271.220(a): Causing contamination, increasing risks
    • 21 CFR 1271.220(c): Specified requirements for in-process controls
    • 21 CFR 1271.270(a): Records incomplete
    • 21 CFR 211.100(b): Procedure Deviations Recorded and Justified
    • 21 CFR 211.194(a)(4): Complete Test Data
    • 21 CFR 211.80(d): Status of Each Lot Identified
    • 21 CFR 820.80(c): Documentation

    Source: FDA Data Dashboard – Citations (FEI 3000233845, inspection ID 1276957)

  2. 30 Jul 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 1276957)

  3. 02 Jun 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.165(e): Test methods

    Source: FDA Data Dashboard – Citations (FEI 3000233845, inspection ID 1207358)

  4. 02 Jun 2023
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 1207358)

  5. 09 Nov 2021
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 1159993)

  6. 30 Mar 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 1053690)

  7. 23 Feb 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 1047037)

  8. 15 Apr 2016
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 966359)

  9. 26 Feb 2016
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls

    Source: FDA Data Dashboard – Citations (FEI 3000233845, inspection ID 987556)

  10. 26 Feb 2016
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Devices, Drugs, Veterinary. Project area(s): Compliance: Devices; Drug Quality Assurance; Human Cellular, Tissue, and Gene Therapies; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 987556)

  11. 25 Jun 2015
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices, Veterinary. Project area(s): Compliance: Devices; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 931827)

  12. 10 Jan 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 862091)

  13. 09 Mar 2012
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Drugs. Project area(s): Drug Quality Assurance; Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 772269)

  14. 08 Mar 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 713601)

  15. 08 Jan 2010
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3000233845, inspection ID 640465)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.