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Eurofins BioPharma Product Testing — Portage

Portage, Michigan, United States · Testing lab

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

Site facts

Company
Eurofins BioPharma Product Testing
Name(s) in FDA data
Eurofins Lancaster Laboratories, Inc
FEI number(s)
1833335 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Portage, Michigan, United States 49002
Records matched
8 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
30 May 2025 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …and NAT Small molecules Supporting your facility Services that span risk identification, method development, sampling, analytical validation, and ongoing monitoring. Disinfectant validation ensures…
  • Microbiology
    …agents are fit for purpose and that your facility is safe for production. A full suite of environmental monitoring services designed to be as rigorous, responsive, and reliable as your cleanroom demands.…

Taken from a company-level page; the company does not publish a separate page for this site, so tags may describe the wider organisation. Source: https://www.eurofins.com/en-us/biopharma-services/biopharma-product-testing/, 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 May 2025
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.160(a): Following/documenting laboratory controls
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1833335, inspection ID 1272016)

  2. 30 May 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 1833335, inspection ID 1272016)

  3. 10 Dec 2021
    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 1833335, inspection ID 1160560)

  4. 23 Jan 2019
    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 1833335, inspection ID 1080439)

  5. 23 Feb 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 1833335, inspection ID 1045298)

  6. 04 Nov 2016
    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 1833335, inspection ID 1001348)

  7. 01 Aug 2014
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.166(a)(1): Sample size - test intervals
    • 21 CFR 211.68(b): input/output verification

    Source: FDA Data Dashboard – Citations (FEI 1833335, inspection ID 889635)

  8. 01 Aug 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1833335, inspection ID 889635)

  9. 25 Apr 2012
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1833335, inspection ID 778568)

  10. 06 May 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 1833335, inspection ID 724139)

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.