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Unither Pharmaceuticals — Coutances

Coutances, France · CDMO

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

Site facts

Company
Unither Pharmaceuticals
Name(s) in FDA data
Laboratoire Unither
FEI number(s)
3006974616 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Coutances, France
Records matched
5 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 Oct 2021 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …ntries where products manufactured for our clients are distributed Expertise and know-how Analytical Development The entire development and production cycle: from formulation to manufacturing and regula…
  • Ophthalmics
    …is one of Unither’s industrial pillars and the world leader in the production of sterile ophthalmic single doses (eye drops). With ever-expanding capacities and recognized expertise in Blow…

Taken from the company's web page for this site. Source: https://www.unither-pharma.com/site/coutances/, 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. 22 Oct 2021
    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 3006974616, inspection ID 1198468)

  2. 21 Jun 2018
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(a): Lab controls established, including changes

    Source: FDA Data Dashboard – Citations (FEI 3006974616, inspection ID 1057672)

  3. 21 Jun 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 3006974616, inspection ID 1057672)

  4. 15 Sep 2015
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.101(d): Component addition checked by 2nd person
    • 21 CFR 211.84(d)(1): Identity Testing of Each Component
    • 21 CFR 211.84(d)(2): Reports of Analysis (Components)

    Source: FDA Data Dashboard – Citations (FEI 3006974616, inspection ID 943780)

  5. 15 Sep 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 3006974616, inspection ID 943780)

  6. 19 Sep 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 3006974616, inspection ID 853044)

  7. 16 May 2011
    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 3006974616, inspection ID 729962)

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.