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Simtra BioPharma Solutions — Bloomington

Bloomington, Indiana, United States · CDMO

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

Site facts

Company
Simtra BioPharma Solutions
Name(s) in FDA data
Simtra US LLC
FEI number(s)
1000115571 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bloomington, Indiana, United States 47403
Records matched
17 FDA inspections · 4 inspections with posted 483 citations
Most recent FDA inspection in dataset
24 Sep 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …oomington, Indiana, provides aseptic formulation, filling and finishing services for both prefilled syringes and vials: Prefilled syringes, 0.5 mL to 20 mL Liquid vials, 2 mL to 100 mL Lyophilized…
  • Lyophilization
    …0+ million facility expansion in Bloomington to add vial and syringe fill lines, increase lyophilization capabilities and support clinical-scale production. We have also acquired an additio…
  • Highly potent (HPAPI)
    …red an additional 65-acre property near our existing facility, enabling us to manufacture high-potency drugs. This dual expansion marks our ongoing commitment to growth and innovation. Read Mo…

Taken from the company's web page for this site. Source: https://simtra.com/our-facilities/bloomington-indiana-usa/, 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. 24 Sep 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 1000115571, inspection ID 1242468)

  2. 17 Feb 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 1000115571, inspection ID 1200813)

  3. 10 Nov 2021
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 1157719)

  4. 23 May 2018
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 1060004)

  5. 17 Jul 2017
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.113(b): Validation lacking for sterile drug products

    Source: FDA Data Dashboard – Citations (FEI 1000115571, inspection ID 1019766)

  6. 17 Jul 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 1000115571, inspection ID 1019766)

  7. 12 May 2016
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 969863)

  8. 24 Oct 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 1000115571, inspection ID 900992)

  9. 02 May 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 1000115571, inspection ID 877455)

  10. 10 May 2013
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.80(a): Procedures To Be in Writing
    • 21 CFR 211.84(d)(3): Certificates of Testing (Containers, Closures)

    Source: FDA Data Dashboard – Citations (FEI 1000115571, inspection ID 831076)

  11. 10 May 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 1000115571, inspection ID 831076)

  12. 12 Mar 2013
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Extent of discrepancy, failure investigations

    Source: FDA Data Dashboard – Citations (FEI 1000115571, inspection ID 821896)

  13. 12 Mar 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 1000115571, inspection ID 821896)

  14. 27 Sep 2012
    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 1000115571, inspection ID 800982)

  15. 16 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 1000115571, inspection ID 739870)

  16. 17 Jun 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 729704)

  17. 25 Mar 2011
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 1000115571, inspection ID 717455)

  18. 25 Mar 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 1000115571, inspection ID 717455)

  19. 23 Sep 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 1000115571, inspection ID 681949)

  20. 24 Mar 2010
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 654293)

  21. 30 Oct 2009
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000115571, inspection ID 630034)

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.