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Recipharm — Leganes

Leganes, Spain · CDMO

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

Site facts

Company
Recipharm
Name(s) in FDA data
Recipharm Leganes SLU
FEI number(s)
3000298591 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Leganes, Spain
Records matched
5 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
26 Oct 2023 — VAI

Capabilities (from the company's website)

  • Highly potent (HPAPI)
    …rly development through to commercial scale. Site capabilities High‑potency OSD expertise OEB4 to OEB5 enabled facility (0.1–1 µg/m³) for safe, efficient handling of potent and cytotox…
  • Oral solid dose
    …rammes from early development through to commercial scale. Site capabilities High‑potency OSD expertise OEB4 to OEB5 enabled facility (0.1–1 µg/m³) for safe, efficient handling of pot…
  • Clinical trial supply & packaging
    …duction of conventional tablets, film‑coated tablets and hard gelatin capsules Integrated packaging solutions including blister packs, plastic bottles and glass bottles Supply to 95+ global…

Taken from the company's web page for this site. Source: https://www.recipharm.com/about-us/locations/leganes, 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. 26 Oct 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 3000298591, inspection ID 1261202)

  2. 05 Oct 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 3000298591, inspection ID 1091302)

  3. 14 Oct 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 3000298591, inspection ID 992010)

  4. 31 Jan 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3000298591, inspection ID 868277)

  5. 31 Jan 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 3000298591, inspection ID 868277)

  6. 05 Feb 2010
    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 3000298591, inspection ID 651878)

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.