Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Greenville

Greenville, North Carolina, 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 Manufacturing Services LLC
FEI number(s)
1018495 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Greenville, North Carolina, United States 27834
Records matched
16 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
30 Jun 2026 — NAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Capabilities Greenville’s clinical and commercial manufacturing services include: Solids Sterile liquids Sterile lyophilization Controlled drugs Secondary packaging of sterile products and soli…
  • Lyophilization
    …both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules. Specialized Capabilities Greenville’…
  • Small molecule
    …and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules. Specialized Capabilities Greenville’s clinical and commercial manufacturing services inc…
  • API / drug substance (chemical)
    …ondary packaging of sterile products and solids Technologies for Solid Dosage Forms Multi-API granulations Dry Coating Encapsulation Modified release formulations Clinical trial mater…
  • Clinical trial supply & packaging
    …ur Greenville, NC site facility is a large, multipurpose pharmaceutical manufacturing and packaging campus. This site provides both solid dose form manufacturing/packaging and sterile dose…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/greenville-nc.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. 30 Jun 2026
    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 1018495, inspection ID 1329462)

  2. 26 Sep 2025
    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 1018495, inspection ID 1270187)

  3. 23 Feb 2024
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(a): Following/documenting laboratory controls

    Source: FDA Data Dashboard – Citations (FEI 1018495, inspection ID 1229060)

  4. 23 Feb 2024
    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 1018495, inspection ID 1229060)

  5. 04 Aug 2022
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.42(a): Buildings of Suitable Size, Construction, Location

    Source: FDA Data Dashboard – Citations (FEI 1018495, inspection ID 1176425)

  6. 04 Aug 2022
    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 1018495, inspection ID 1176425)

  7. 17 May 2019
    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 1018495, inspection ID 1096860)

  8. 17 Jul 2018
    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 1018495, inspection ID 1060475)

  9. 28 Mar 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1018495, inspection ID 1055334)

  10. 20 Apr 2017
    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 1018495, inspection ID 1019511)

  11. 17 Dec 2015
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.103: Actual vs. theoretical yields not determined
    • 21 CFR 211.142(b): Storage under appropriate conditions
    • 21 CFR 211.160(a): Following/documenting laboratory controls

    Source: FDA Data Dashboard – Citations (FEI 1018495, inspection ID 985597)

  12. 17 Dec 2015
    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; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1018495, inspection ID 985597)

  13. 12 Sep 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 1018495, inspection ID 896809)

  14. 11 Apr 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 1018495, inspection ID 876160)

  15. 25 Jan 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 1018495, inspection ID 840598)

  16. 20 Apr 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 1018495, inspection ID 778578)

  17. 21 Apr 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 1018495, inspection ID 744550)

  18. 18 Jun 2010
    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 1018495, inspection ID 669033)

  19. 02 Sep 2009
    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 1018495, inspection ID 613370)

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.