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Eurofins BioPharma Product Testing — Lancaster

Lancaster, Pennsylvania, 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, LLC
FEI number(s)
2513291 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Lancaster, Pennsylvania, United States 17601
Records matched
13 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
23 Sep 2025 — NAI

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. 23 Sep 2025
    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 2513291, inspection ID 1284580)

  2. 26 Aug 2025
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.165(b): Microbiological testing
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 2513291, inspection ID 1279557)

  3. 26 Aug 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 2513291, inspection ID 1279557)

  4. 21 Oct 2021
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 2513291, inspection ID 1156933)

  5. 17 Oct 2019
    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 2513291, inspection ID 1113269)

  6. 13 Sep 2019
    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 2513291, inspection ID 1106449)

  7. 28 Sep 2017
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 2513291, inspection ID 1029560)

  8. 19 Jun 2015
    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 2513291, inspection ID 931350)

  9. 14 Apr 2014
    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 2513291, inspection ID 874243)

  10. 27 Jun 2013
    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 2513291, inspection ID 838046)

  11. 17 May 2012
    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 2513291, inspection ID 782066)

  12. 25 Jan 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 2513291, inspection ID 707238)

  13. 07 Sep 2010
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(b)(4): Calibration - at intervals, written program, remedial action

    Source: FDA Data Dashboard – Citations (FEI 2513291, inspection ID 681727)

  14. 07 Sep 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 2513291, inspection ID 681727)

  15. 06 Oct 2009
    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 2513291, inspection ID 631027)

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.