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Hovione — Loures

Loures, Portugal · CDMO

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

Site facts

Company
Hovione
Name(s) in FDA data
Hovione FarmaCiencia SA
FEI number(s)
3002807208 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Loures, Portugal
Records matched
11 FDA inspections
Most recent FDA inspection in dataset
24 Oct 2024 — VAI

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. 24 Oct 2024
    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 3002807208, inspection ID 1281614)

  2. 10 Mar 2023
    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 3002807208, inspection ID 1200271)

  3. 12 Nov 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 3002807208, inspection ID 1203729)

  4. 03 Nov 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 3002807208, inspection ID 1037736)

  5. 26 Feb 2016
    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 3002807208, inspection ID 959920)

  6. 05 Dec 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 3002807208, inspection ID 906066)

  7. 27 Sep 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 3002807208, inspection ID 853494)

  8. 01 Mar 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Project Evaluation: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002807208, inspection ID 822152)

  9. 29 Apr 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 3002807208, inspection ID 725880)

  10. 27 Jan 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 3002807208, inspection ID 708695)

  11. 25 Sep 2009
    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 3002807208, inspection ID 619052)

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.