Directory › Vetter

Vetter — Langenargen

Langenargen, Germany · CDMO

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

Site facts

Company
Vetter
Name(s) in FDA data
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)
FEI number(s)
3002808846 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Langenargen, Germany
Records matched
9 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
20 Mar 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …on network. It has played a key role in our global success since 1998. Snapshot Versatile aseptic filling support VLA is home to 5 of Vetter’s 20 active filling lines, including resources to p…
  • Lyophilization
    …to 5 of Vetter’s 20 active filling lines, including resources to process both liquid and lyophilized products in vials and syringes. Key features & resources: Aseptic filling facilities Ch…
  • Microbiology
    …and syringes. Key features & resources: Aseptic filling facilities Chemical analysis and Microbiology Investments Expanded aseptic filling capacity Further optimization of VLA will be a crit…

Taken from the company's web page for this site. Source: https://www.vetter-pharma.com/en/locations/commercial-manufacturing/production-langenargen/, 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 Mar 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 3002808846, inspection ID 1337464)

  2. 24 May 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 3002808846, inspection ID 1205983)

  3. 13 Sep 2019
    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 3002808846, inspection ID 1129699)

  4. 21 Sep 2018
    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 3002808846, inspection ID 1070717)

  5. 10 Nov 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 3002808846, inspection ID 1031350)

  6. 26 Apr 2016
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.100(b): Procedure Deviations Recorded and Justified
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.198(a): Complaint Handling Procedure
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 3002808846, inspection ID 1001330)

  7. 26 Apr 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 3002808846, inspection ID 1001330)

  8. 20 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 3002808846, inspection ID 873643)

  9. 17 Jul 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 3002808846, inspection ID 791473)

  10. 01 Apr 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 3002808846, inspection ID 658300)

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.