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Hovione — East Windsor

East Windsor, New Jersey, United States · CDMO

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

Site facts

Company
Hovione
Name(s) in FDA data
Hovione LLC
FEI number(s)
3006106736 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
East Windsor, New Jersey, United States 08520
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
11 Jun 2025 — 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. 11 Jun 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 3006106736, inspection ID 1269771)

  2. 22 Jan 2020
    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 3006106736, inspection ID 1116753)

  3. 16 Dec 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 3006106736, inspection ID 953507)

  4. 26 Apr 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 3006106736, inspection ID 829292)

  5. 02 May 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 3006106736, inspection ID 724233)

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.