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Siegfried — Hameln

Hameln, Germany · CDMO

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

Site facts

Company
Siegfried
Name(s) in FDA data
Siegfried Hameln GmbH
FEI number(s)
3002807877 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Hameln, Germany
Records matched
7 FDA inspections · 1 inspection with posted 483 citations · 1 warning letter
Most recent FDA inspection in dataset
29 Aug 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …n is one of Siegfried’s six Drug Products sites globally. It is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in PFS, c…

Taken from the part of the company's network/locations page that describes this site. Source: https://www.siegfried.ch/company/locations/, 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. 29 Aug 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 3002807877, inspection ID 1338372)

  2. 01 Sep 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 3002807877, inspection ID 1203347)

  3. 24 Apr 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices, Drugs. Project area(s): Compliance: Devices; Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002807877, inspection ID 1050123)

  4. 01 Jul 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 3002807877, inspection ID 987428)

  5. 25 Jul 2014
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.180(e): Records reviewed annually
    • 21 CFR 211.25(a): GMP Training Frequency
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures

    Source: FDA Data Dashboard – Citations (FEI 3002807877, inspection ID 887446)

  6. 25 Jul 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 3002807877, inspection ID 887446)

  7. 21 Dec 2012
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 3002807877; case/injunction ID 363318.

    Source: FDA Data Dashboard – Compliance Actions (FEI 3002807877, case 363318)

  8. 14 Jun 2012
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002807877, inspection ID 786813)

  9. 09 Nov 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 3002807877, inspection ID 637807)

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.