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Eurofins BioPharma Product Testing — Cary

Cary, North Carolina, 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 BioPharma Product Testing ENCO, LLC
FEI number(s)
3009827154 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Cary, North Carolina, United States 27511
Records matched
4 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
01 Aug 2025 — NAI

Capabilities (from the company's website)

  • Analytical testing
    …halmic services include a range of capabilities including analytical characterization and stability storage, assay, related substances, extractable and leachable characterizations of ophthalmic dev…
  • Microbiology
    …e and leachable characterizations of ophthalmic devices. Other Eurofins BPT sites provide microbiological tests such as sterility, preservative efficacy testing, and endotoxin testing. Our ex…
  • Medical device testing
    …ENCO expands EBPT’s ophthalmic and medical device capabilities Published Date : Thursday, May 18, 2023 Tags : Newsletter Rick Camp Medical…

Taken from the company's web page for this site. Source: https://www.eurofins.com/en-us/biopharma-services/biopharma-product-testing/news/enco-expands-ebpt-s-ophthalmic-and-medical-device-capabilities/, 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. 01 Aug 2025
    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 3009827154, inspection ID 1279054)

  2. 12 Jan 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 3009827154, inspection ID 1041344)

  3. 11 Jul 2014
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(a): Lab controls established, including changes
    • 21 CFR 211.194(d): Laboratory equipment calibration records
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 212.60(f): Lab written procedures

    Source: FDA Data Dashboard – Citations (FEI 3009827154, inspection ID 889761)

  4. 11 Jul 2014
    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 3009827154, inspection ID 889761)

  5. 14 Feb 2013
    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 3009827154, inspection ID 822786)

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.