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CordenPharma — Caponago

Caponago, Italy · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
CordenPharma
Name(s) in FDA data
Corden Pharma S.p.A.
FEI number(s)
3002880938 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Caponago, Italy
Records matched
8 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
28 Mar 2025 — VAI

Capabilities (from the company's website)

  • mRNA & lipid nanoparticles
    …ty Fact Sheet Drug Products Research & Development GMP Manufacturing Phase I-II Phase III LNP Formulation Regulatory Approval Commercialization Drug Products Drug Product Support Serv…

Taken from the part of the company's network/locations page that describes this site. Source: https://cordenpharma.com/how-we-deliver/facilities-network/, 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. 28 Mar 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 3002880938, inspection ID 1327684)

  2. 02 Dec 2022
    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 3002880938, inspection ID 1207569)

  3. 14 Jun 2019
    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 3002880938, inspection ID 1124670)

  4. 10 Jul 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3002880938, inspection ID 1061242)

  5. 15 Jul 2016
    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.

    Source: FDA Data Dashboard – Inspections (FEI 3002880938, inspection ID 981653)

  6. 14 Mar 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 3002880938, inspection ID 881536)

  7. 28 Oct 2011
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.188: Prepared for each batch, include complete information
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures
    • 21 CFR 211.28(a): Protective Apparel Not Worn
    • 21 CFR 211.56(c): Written procedures lacking for use of pesticides etc.
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3002880938, inspection ID 756036)

  8. 28 Oct 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 3002880938, inspection ID 756036)

  9. 16 Jul 2009
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.165(b): Microbiological testing

    Source: FDA Data Dashboard – Citations (FEI 3002880938, inspection ID 601486)

  10. 16 Jul 2009
    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 3002880938, inspection ID 601486)

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.