Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — High Point

High Point, 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 Softgels Inc
FEI number(s)
3001451366 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
High Point, North Carolina, United States 27265
Records matched
10 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
17 Jul 2025 — VAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …pounds and bioavailability enhancement Tablet to softgel form change development Low dose API product development Modified release formulation Formulation & development capabilities a…
  • Highly potent (HPAPI)
    …nalytical Method Development and Validation Clinical Manufacturing up to Commercial Scale Potent Compounding Suite Applications Laboratory Finished Product Stability Studies The High Point, NC fa…
  • Oral solid dose
    …ith use of gelatin from different origin: bovine bone, porcine, and non-animal source for capsules Color matching and development for dosage forms Formulation development for low solubilit…
  • Softgels
    …High Point, North Carolina, US Contact us Download fact sheet Softgels High Point, NC is a commercial manufacturing and development site focusing on gelatin bas…
  • Analytical testing
    …odified release formulation Formulation & development capabilities at High Point include: Analytical Method Development and Validation Clinical Manufacturing up to Commercial Scale Potent Compoundi…
  • Formulation & process development
    …rcine, and non-animal source for capsules Color matching and development for dosage forms Formulation development for low solubility compounds and bioavailability enhancement Tablet to softgel form chang…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/high-point-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. 17 Jul 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.188(b): Batch production and Batch Control Record Requirements
    • 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 3001451366, inspection ID 1251557)

  2. 17 Jul 2025
    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 3001451366, inspection ID 1251557)

  3. 30 Jan 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 3001451366, inspection ID 1080798)

  4. 11 Aug 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 3001451366, inspection ID 1023652)

  5. 29 Jan 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 3001451366, inspection ID 912784)

  6. 18 Sep 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 3001451366, inspection ID 852044)

  7. 26 Sep 2012
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3001451366, inspection ID 801960)

  8. 02 Jul 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 3001451366, inspection ID 789295)

  9. 06 Jun 2012
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 111.353: Manufacturing operations - written procedures
    • 21 CFR 111.365: Manufacturing operations - prevent contamination

    Source: FDA Data Dashboard – Citations (FEI 3001451366, inspection ID 785441)

  10. 06 Jun 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 3001451366, inspection ID 785441)

  11. 14 Sep 2010
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3001451366, inspection ID 684621)

  12. 21 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 3001451366, inspection ID 612191)

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.