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Nelson Labs — Itasca

Itasca, Illinois, 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)
3000717698 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Itasca, Illinois, United States 60143
Records matched
6 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
26 Sep 2025 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …) test support with Analytical Research & Development (ARD), Raw Materials Testing (RMT), Stability studies and routine Quality Control batch release tests with both microbiological and analytical…
  • Microbiology
    …esting (RMT), Stability studies and routine Quality Control batch release tests with both microbiological and analytical capabilities. The facility is ISO 17025 accredited and can more fully…
  • Extractables & leachables
    …g Assay (Active Ingredient and Dosage Forms) Excipient Testing Wet Chemistry Capabilities Extractables & Leachables Material Characterization Screens of Raw Materials Physicochemical USP Plast…
  • Medical device testing
    …n of Nonsterile Products Microbial Identifications Particulate Matter Product Bioburden – Medical Device Product Bioburden – Tissue Product Sterility – Cleanroom Product Sterility – Isolator Rad…

Taken from the company's web page for this site. Source: https://www.nelsonlabs.com/locations/itasca-illinois-usa/, 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. 26 Sep 2025
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(b)(4): Test devices not meeting specifications
    • 21 CFR 211.166(a)(2): Stability sample storage conditions described
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.68(b): input/output verification

    Source: FDA Data Dashboard – Citations (FEI 3000717698, inspection ID 1283842)

  2. 26 Sep 2025
    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 3000717698, inspection ID 1283842)

  3. 08 Nov 2018
    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 3000717698, inspection ID 1073798)

  4. 11 Mar 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 3000717698, inspection ID 961743)

  5. 11 Mar 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 3000717698, inspection ID 961743)

  6. 12 Jun 2013
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Devices, Drugs, Food/Cosmetics. Project area(s): Compliance: Devices; Drug Quality Assurance; Food Composition, Standards, Labeling and Econ; Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3000717698, inspection ID 835477)

  7. 07 Dec 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics, Devices, Drugs. Project area(s): Compliance: Devices; Drug Quality Assurance; Human Cellular, Tissue, and Gene Therapies; Postmarket Assurance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3000717698, inspection ID 759436)

  8. 08 Oct 2010
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3000717698, inspection ID 684290)

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.