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Hovione — Ringaskiddy

Ringaskiddy, Ireland · CDMO

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

Site facts

Company
Hovione
Name(s) in FDA data
Hovione Limited
FEI number(s)
3008058822 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Ringaskiddy, Ireland
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
20 Jan 2023 — NAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …. Hovione has over 60 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites , USA, China, Ireland and…
  • Highly potent (HPAPI)
    …services for the development and compliant manufacture of innovative new drugs including highly potent compounds . For generic pharmaceutical customers the company offers niche generic API pro…
  • Inhalation & nasal
    …r generic pharmaceutical customers the company offers niche generic API products . In the inhalation area, Hovione is the only independent company offering a complete range of services.…

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.hovione.com/about-us/about-hovione/what-we-do, 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. 20 Jan 2023
    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 3008058822, inspection ID 1199699)

  2. 22 Feb 2022
    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 3008058822, inspection ID 1272148)

  3. 22 Dec 2017
    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 3008058822, inspection ID 1041771)

  4. 25 Jul 2014
    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 3008058822, inspection ID 888564)

  5. 16 Mar 2012
    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 3008058822, inspection ID 776330)

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.