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Rentschler Biopharma — Laupheim

Laupheim, Germany · CDMO

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

Site facts

Company
Rentschler Biopharma
Name(s) in FDA data
Rentschler Biopharma SE
FEI number(s)
1000291122 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Laupheim, Germany
Records matched
7 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
05 May 2023 — VAI

Capabilities (from the company's website)

  • Formulation & process development
    …-approved biopharmaceuticals in 2023. Our services We offer full-service solutions for bioprocess development and manufacturing of high-quality biopharmaceuticals Fueled by 50 years of experience in…

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.rentschler-biopharma.com/, 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. 05 May 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 1000291122, inspection ID 1246782)

  2. 26 Feb 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 1000291122, inspection ID 1160831)

  3. 09 Aug 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 1000291122, inspection ID 1102650)

  4. 06 Dec 2016
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.63: Equipment Design, Size and Location

    Source: FDA Data Dashboard – Citations (FEI 1000291122, inspection ID 999800)

  5. 06 Dec 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 1000291122, inspection ID 999800)

  6. 16 Jun 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 1000291122, inspection ID 933400)

  7. 20 Sep 2013
    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 1000291122, inspection ID 853179)

  8. 19 Jul 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 1000291122, inspection ID 744719)

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.