Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Florence

Florence, South 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 API, INC.
FEI number(s)
3000717636 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Florence, South Carolina, United States 29506
Records matched
6 FDA inspections
Most recent FDA inspection in dataset
12 Jun 2026 — NAI

Capabilities (from the company's website)

  • Small molecule
    …0,000,000 Scalable production capabilities, short lead time capacity expansion, available small molecule drug substance production and milling capacity, as well as high potency manufacturing Exc…
  • API / drug substance (chemical)
    …Florence, SC (East) Contact us Download fact sheet Active pharmaceutical ingredient (API) Our Florence, SC (East) site is a flexible drug substance manufacturing site offeri…
  • Highly potent (HPAPI)
    …PI) Our Florence, SC (East) site is a flexible drug substance manufacturing site offering highly potent compound handling, process development and scale up and large-scale and mid-scale API pro…
  • Spray drying & particle engineering
    …le and mid-scale API production. The site also has capabilities in solid state chemistry, spray drying, and micronization. The facility is fully compliant with all applicable regulations a…
  • Solid-state & particle characterization
    …scale up and large-scale and mid-scale API production. The site also has capabilities in solid state chemistry, spray drying, and micronization. The facility is fully compliant with all appl…
  • Formulation & process development
    …is a flexible drug substance manufacturing site offering highly potent compound handling, process development and scale up and large-scale and mid-scale API production. The site also has capabilities…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/florence-sc-east.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. 12 Jun 2026
    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 3000717636, inspection ID 1323514)

  2. 28 Jun 2024
    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 3000717636, inspection ID 1245266)

  3. 09 Nov 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 3000717636, inspection ID 1077371)

  4. 19 Dec 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 3000717636, inspection ID 911327)

  5. 08 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 3000717636, inspection ID 792356)

  6. 27 Jan 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 3000717636, inspection ID 642833)

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.