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Simtra BioPharma Solutions — Halle (Westf.)

Halle (Westf.), Germany · CDMO

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

Site facts

Company
Simtra BioPharma Solutions
Name(s) in FDA data
Simtra Deutschland GmbH
FEI number(s)
3002806419 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Halle (Westf.), Germany
Records matched
11 FDA inspections · 2 inspections with posted 483 citations · 1 warning letter
Most recent FDA inspection in dataset
26 Sep 2025 — OAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …pansion Current Manufacturing Services Our facility in Halle/Westfalen currently provides aseptic manufacturing of two types of vials: Lyophilized vials, 2 mL to 100 mL Liquid vials, 2 mL to 100 mL…
  • Lyophilization
    …xpansion to offer clients syringe manufacturing capacity as well as additional liquid and lyophilized vial capacity. Read More About the Expansion Current Manufacturing Services Our facilit…
  • Highly potent (HPAPI)
    …fied facility in Halle/Westfalen, Germany, is recognized as a world-class manufacturer of cytotoxic and highly potent drugs. Halle/Westfalen currently offers dedicated clinical through comm…

Taken from the company's web page for this site. Source: https://simtra.com/our-facilities/halle-westfalen-germany/, 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. 03 Mar 2026
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 3002806419; case/injunction ID 720436. Letter subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).

    Source: FDA warning letter (fda.gov) · FDA Data Dashboard – Compliance Actions (FEI 3002806419, case 720436)

  2. 26 Sep 2025
    Form 483 observations 12 posted Form 483 citation(s)

    Citation summaries (12)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.186(a): Written procedures followed
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.22(a): Authority lacking to review records, investigate errors
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.42(c)(10)(v): Cleaning System
    • 21 CFR 211.56(a): Sanitation--buildings not clean, free of infestation
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3002806419, inspection ID 1283802)

  3. 26 Sep 2025
    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 3002806419, inspection ID 1283802)

  4. 03 May 2023
    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 3002806419, inspection ID 1206312)

  5. 29 Jan 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 3002806419, inspection ID 1161093)

  6. 03 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 3002806419, inspection ID 1106642)

  7. 14 Jun 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 3002806419, inspection ID 1056958)

  8. 27 Jun 2017
    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 3002806419, inspection ID 1019700)

  9. 18 Mar 2016
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.28(b): Habits of good sanitation & health
    • 21 CFR 211.42(b): Product flow through building is inadequate
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.46(b): Equipment for Environmental Control

    Source: FDA Data Dashboard – Citations (FEI 3002806419, inspection ID 967376)

  10. 18 Mar 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 3002806419, inspection ID 967376)

  11. 01 Jul 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 3002806419, inspection ID 888909)

  12. 20 Jul 2013
    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 3002806419, inspection ID 845264)

  13. 26 Aug 2011
    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 3002806419, inspection ID 747007)

  14. 22 Jul 2010
    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 3002806419, inspection ID 681781)

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.