Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Ridgefield

Ridgefield, New Jersey, 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)
2246315 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Ridgefield, New Jersey, United States 07657
Records matched
11 FDA inspections · 6 inspections with posted 483 citations
Most recent FDA inspection in dataset
13 Jun 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Ridgefield, New Jersey, USA Sterile fill-finish and packaging facility Contact us Download fact sheet Steriles Our state-of-the-art steri…
  • Clinical trial supply & packaging
    …Ridgefield, New Jersey, USA Sterile fill-finish and packaging facility Contact us Download fact sheet Steriles Our state-of-the-art sterile fill-finish…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/ridgefield-nj.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. 13 Jun 2024
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 1230469)

  2. 13 Jun 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 2246315, inspection ID 1230469)

  3. 18 Mar 2024
    Form 483 observations 1 posted Form 483 citation(s)

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

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 1230688)

  4. 18 Mar 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 2246315, inspection ID 1230688)

  5. 17 Dec 2018
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 803.50(a)(1): Report of Death or Serious Injury
    • 21 CFR 820.100(a): Lack of or inadequate procedures
    • 21 CFR 820.198(a): Lack of or inadequate complaint procedures
    • 21 CFR 820.70(a): Process control procedures, Lack of or inadequate procedures
    • 21 CFR 820.75(a): Lack of or inadequate process validation

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 1076243)

  6. 17 Dec 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Devices. Project area(s): Compliance: Devices; Postmarket Assurance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 2246315, inspection ID 1076243)

  7. 07 Dec 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 2246315, inspection ID 1039401)

  8. 26 Aug 2015
    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 2246315, inspection ID 938525)

  9. 21 Jan 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 861702)

  10. 21 Jan 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 2246315, inspection ID 861702)

  11. 12 Sep 2012
    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 2246315, inspection ID 795428)

  12. 21 Jun 2011
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.110(a): Written in-process control procedures
    • 21 CFR 211.84(e): Rejecting When Specifications Not Met

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 731289)

  13. 21 Jun 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 2246315, inspection ID 731289)

  14. 21 Dec 2010
    Form 483 observations 11 posted Form 483 citation(s)

    Citation summaries (11)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.186(b)(3): Components complete listing
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.42(c): Defined areas of adequate size for operations
    • 21 CFR 211.46(c): Exhaust systems inadequate to control air contamination
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done
    • 21 CFR 211.68(b): input/output verification
    • 21 CFR 211.80(a): Written Procedures Not Followed
    • 21 CFR 314.81(b)(1)(ii): Contamination, chemical or physical change, deterioration

    Source: FDA Data Dashboard – Citations (FEI 2246315, inspection ID 697759)

  15. 21 Dec 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 2246315, inspection ID 697759)

  16. 02 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 2246315, inspection ID 682898)

  17. 19 Mar 2009
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 2246315, inspection ID 571628)

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.