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Catalent — Buenos Aires

Buenos Aires, Argentina · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Argentina S.A.I.C.
FEI number(s)
3004258511 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Buenos Aires, Argentina
Records matched
6 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
09 Nov 2023 — VAI

Capabilities (from the company's website)

  • Small molecule
    …solutions. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule Dietary Supplements OTC Facility Type Development Manufacturing Commercialization Innovat…
  • Softgels
    …Buenos Aires Buenos Aires, Argentina Our Buenos Aires, Argentina facility is dedicated to softgel manufacturing and development. Leveraging deep expertise, we deliver comprehensive, end-t…
  • Clinical trial supply & packaging
    …tary Supplements OTC Facility Type Development Manufacturing Commercialization Innovation Packaging Certifications Highlights FDA EMEA ANMAT MHRA ANVISA COFEPRIS INVIMA FIMEA Size 265,000 s…
  • Analytical testing
    …e, we deliver comprehensive, end-to-end programs—from initial formulation design to final stability studies and regulatory dossier preparation. In addition, the facility offers a broad portfolio of…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/buenos-aires-argentina, 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. 09 Nov 2023
    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 3004258511, inspection ID 1336632)

  2. 04 Aug 2023
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.42(c): Defined areas of adequate size for operations

    Source: FDA Data Dashboard – Citations (FEI 3004258511, inspection ID 1211696)

  3. 04 Aug 2023
    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 3004258511, inspection ID 1211696)

  4. 22 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 3004258511, inspection ID 1038458)

  5. 16 May 2014
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.160(b)(3): Drug products - samples representative, identified properly
    • 21 CFR 211.198(a): Complaint Handling Procedure
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 3004258511, inspection ID 881348)

  6. 16 May 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 3004258511, inspection ID 881348)

  7. 14 Sep 2012
    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 3004258511, inspection ID 803767)

  8. 02 Jul 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 3004258511, inspection ID 604132)

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.