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Catalent — Schorndorf

Schorndorf, Germany · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Germany Schorndorf GmbH
FEI number(s)
3003831171 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Schorndorf, Germany
Records matched
7 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
17 Mar 2022 — VAI

Capabilities (from the company's website)

  • Small molecule
    …Location Hub Schorndorf - Small Molecule Baden-Württemberg, Germany Catalent’s Schorndorf facility is our Oral Solid Center of Exc…
  • Oral solid dose
    …orndorf - Small Molecule Baden-Württemberg, Germany Catalent’s Schorndorf facility is our Oral Solid Center of Excellence in Europe for innovative pharmaceutical development, manufacturing,…
  • Clinical trial supply & packaging
    …Center of Excellence in Europe for innovative pharmaceutical development, manufacturing, packaging and clinical trial support. Contact Us About This Site View Job Openings Facility at a Gl…
  • Formulation & process development
    …cility provides end‑to‑end capabilities across the oral solid dosage lifecycle, including formulation development, analytical support, scale-up and commercial manufacturing of complex controlled‑release…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/schorndorf-germany-pch, 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. 17 Mar 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 3003831171, inspection ID 1205903)

  2. 14 Feb 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 3003831171, inspection ID 1127864)

  3. 21 Sep 2018
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.188(b)(5): In-Process and Laboratory Control Results

    Source: FDA Data Dashboard – Citations (FEI 3003831171, inspection ID 1066669)

  4. 21 Sep 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 3003831171, inspection ID 1066669)

  5. 26 Oct 2016
    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 3003831171, inspection ID 996275)

  6. 07 Feb 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 3003831171, inspection ID 868435)

  7. 10 Feb 2012
    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 3003831171, inspection ID 772774)

  8. 03 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 3003831171, inspection ID 620300)

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.