Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Cincinnati

Cincinnati, Ohio, United States · CDMO

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

Site facts

Company
Thermo Fisher Scientific (Patheon)
Name(s) in FDA data
Patheon Pharmaceuticals Inc.
FEI number(s)
1510437 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Cincinnati, Ohio, United States 45237
Records matched
15 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
26 Sep 2025 — VAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …e lifecycle of their molecule. Specialized Capabilities Our Cincinnati site handles Cat 2 APIs and offers select suites for Cat 3 APIs. The specialized capabilities listed below are su…
  • Highly potent (HPAPI)
    …rogram) Compaction simulation and FT4 powder rheometer Non-GMP laboratory (manufacturing) Potent compound processing (Cat 3A) Regulatory compliance Over the past five years, our Cincinnati facili…
  • Oral solid dose
    …Cincinnati, Ohio, US Contact us Download fact sheet Oral solid dose $7 million investment In September 2024, we expanded the flexibility of our oral sol…
  • Controlled substances
    …oral dosage forms Osmotic release dosage forms (laser drilling) Liquid fill hard capsules Controlled substances manufacturing Abuse-deterrent dosage forms By integrating scalable and flexible drug dev…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/cincinnati-oh.html, 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. 26 Sep 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 1510437, inspection ID 1281564)

  2. 26 Sep 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). 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 1510437, inspection ID 1281564)

  3. 21 Apr 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 1510437, inspection ID 1204466)

  4. 14 Jan 2020
    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 1510437, inspection ID 1117783)

  5. 14 Feb 2018
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.56(a): Sanitation--buildings not clean, free of infestation
    • 21 CFR 211.58: Buildings not maintained in good state of repair
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 1510437, inspection ID 1040994)

  6. 14 Feb 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 1510437, inspection ID 1040994)

  7. 02 Mar 2017
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.100(b): SOPs not followed / documented

    Source: FDA Data Dashboard – Citations (FEI 1510437, inspection ID 1003802)

  8. 02 Mar 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 1510437, inspection ID 1003802)

  9. 11 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 1510437, inspection ID 966241)

  10. 30 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 1510437, inspection ID 908474)

  11. 18 Jun 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 1510437, inspection ID 884564)

  12. 26 Aug 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 1510437, inspection ID 847969)

  13. 13 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 1510437, inspection ID 832290)

  14. 16 Aug 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 1510437, inspection ID 793752)

  15. 12 Jan 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 1510437, inspection ID 769732)

  16. 24 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 1510437, inspection ID 722010)

  17. 31 Jan 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 1510437, inspection ID 707714)

  18. 24 Mar 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 1510437, inspection ID 653143)

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.