Directory › Thermo Fisher Scientific (Patheon)
Thermo Fisher Scientific (Patheon) — Ferentino
Ferentino, Italy · CDMO
Site facts
- Company
- Thermo Fisher Scientific (Patheon)
- Name(s) in FDA data
- Patheon Italia S.p.A
- FEI number(s)
- 3004110157 (present in FDA Data Dashboard records for this name and city)
- Location (as in FDA data)
- Ferentino, Italy
- Records matched
- 12 FDA inspections · 1 inspection with posted 483 citations
- Most recent FDA inspection in dataset
- 30 Jan 2026 — NAI
Capabilities (from the company's website)
- Sterile fill-finish
…sheet Steriles Ferentino is a 14,034 m2 (151,061 ft2) facility specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, including high potency…
- Lyophilization
…ntino is a 14,034 m2 (151,061 ft2) facility specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, including high potency products and L…
- Biologics drug substance
…Specialized Capabilities Sterile Liquid vials (SVP & LVP) Biopharmaceuticals, including: Monoclonal antibodies Other recombinant proteins Monoclonal antibodies Proteins Peptides Sterile Lyophilized…
- Small molecule
…clonal antibodies Proteins Peptides Sterile Lyophilized vials Secondary packaging (vials) Small molecules Scale up Blood product High-Potency Capabilities Our Ferentino Facility has high-potency…
- Highly potent (HPAPI)
…terile liquid and lyophilized product development and commercial manufacturing, including high potency products and LVP. Specialized Capabilities Sterile Liquid vials (SVP & LVP) Biopharmaceut…
- Peptides & oligonucleotides
…ncluding: Monoclonal antibodies Other recombinant proteins Monoclonal antibodies Proteins Peptides Sterile Lyophilized vials Secondary packaging (vials) Small molecules Scale up Blood prod…
- Clinical trial supply & packaging
…nant proteins Monoclonal antibodies Proteins Peptides Sterile Lyophilized vials Secondary packaging (vials) Small molecules Scale up Blood product High-Potency Capabilities Our Ferentino Fa…
Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/ferentino-it.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.
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30 Jan 2026FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 1306942)
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14 Jun 2022FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 1174972)
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25 Feb 2022FDA 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 3004110157, inspection ID 1247104)
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21 Sep 2018FDA 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 3004110157, inspection ID 1066263)
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31 Oct 2016FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 1006748)
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16 Dec 2015FDA 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 3004110157, inspection ID 955569)
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19 May 2015FDA inspection FDA inspection classified OAI
Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 926682)
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31 Oct 2013FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 853759)
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21 Jun 2013Form 483 observations 6 posted Form 483 citation(s)
Citation summaries (6)
- 21 CFR 211.110(a): Control procedures to monitor and validate performance
- 21 CFR 211.122(d): Labels and labeling stored separately
- 21 CFR 211.198(a): Complaint Handling Procedure
- 21 CFR 211.22(d): Procedures not in writing, fully followed
- 21 CFR 211.67(c): Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2): Reports of Analysis (Components)
Source: FDA Data Dashboard – Citations (FEI 3004110157, inspection ID 841054)
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21 Jun 2013FDA 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 3004110157, inspection ID 841054)
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11 Nov 2011FDA 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 3004110157, inspection ID 762598)
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30 May 2011FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 741229)
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22 Jun 2009FDA 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 3004110157, inspection ID 595171)
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.