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Pace Life Sciences — Oakdale

Oakdale, Minnesota, United States · Testing lab

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

Site facts

Company
Pace Life Sciences
Name(s) in FDA data
Pace Analytical Life Sciences, LLC
FEI number(s)
3001452367 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Oakdale, Minnesota, United States 55128
Records matched
6 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
29 May 2026 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …ontract Research Organization (CRO) FDA-registered DEA-registered 50,000 ft² of Lab Space Analytical Testing for More Than 25 Years Core Services: Raw Materials Clearance Programs Methods Developmen…
  • Microbiology
    …Programs ICH Stability Programs Reference Standards Programs Extractables/Leachables Full Microbiology Laboratory Support Sterile & Non-sterile Product Support Contact Us Contact Us Get Direc…
  • Extractables & leachables
    …shed Product Release Testing Programs ICH Stability Programs Reference Standards Programs Extractables/Leachables Full Microbiology Laboratory Support Sterile & Non-sterile Product Support Con…

Taken from the company's web page for this site. Source: https://www.pacelabs.com/company/lab-results/oakdale/, 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. 29 May 2026
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.68(b): input/output verification

    Source: FDA Data Dashboard – Citations (FEI 3001452367, inspection ID 1319822)

  2. 29 May 2026
    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 3001452367, inspection ID 1319822)

  3. 19 Jul 2024
    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 3001452367, inspection ID 1245318)

  4. 07 Feb 2018
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 3001452367, inspection ID 1042666)

  5. 07 Feb 2018
    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 3001452367, inspection ID 1042666)

  6. 04 May 2015
    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 3001452367, inspection ID 925785)

  7. 08 Apr 2013
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Extent of discrepancy, failure investigations

    Source: FDA Data Dashboard – Citations (FEI 3001452367, inspection ID 826239)

  8. 08 Apr 2013
    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 3001452367, inspection ID 826239)

  9. 07 Feb 2011
    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 3001452367, inspection ID 708788)

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.