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Catalent — Saint Petersburg

Saint Petersburg, Florida, United States · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Pharma Solutions, LLC
FEI number(s)
1811396 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Saint Petersburg, Florida, United States 33716
Records matched
12 FDA inspections · 4 inspections with posted 483 citations
Most recent FDA inspection in dataset
30 Jan 2026 — VAI

Capabilities (from the company's website)

  • Small molecule
    …n options. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule OTC Facility Type Development Manufacturing Commercialization Innovation Packaging Certif…
  • Oral solid dose
    …oduct Launches Small Molecule Commercialization Softgel Commercial CGMP Manufacturing for Oral Solid & Liquid Tech Transfers & Product Launches Quality & Certifications Certifications EMA/MH…
  • Softgels
    …mall Molecule Development Preclinical Bioavailability Enhancement Lipid-based formulation Softgel Small Molecule Manufacturing Softgel Tech Transfers & Product Launches Small Molecule Com…
  • Clinical trial supply & packaging
    …a Small Molecule OTC Facility Type Development Manufacturing Commercialization Innovation Packaging Certifications Highlights EMA/MHRA Approved FDA Approved ANVISA PMDA CFDA (China) MOH (Sa…
  • Analytical testing
    …clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical lab…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/st-petersburg-united-states, 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. 30 Jan 2026
    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 1811396, inspection ID 1282788)

  2. 30 May 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 1811396, inspection ID 1229815)

  3. 25 Jan 2024
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 1229344)

  4. 21 Jul 2023
    Form 483 observations 8 posted Form 483 citation(s)

    Citation summaries (8)
    • 21 CFR 111.205(a): Master manufacturing record - unique formulation
    • 21 CFR 111.255(b): Batch record - complete
    • 21 CFR 111.27(d): Equipment - maintain, clean, sanitize
    • 21 CFR 111.70(b)(1): Specifications - component identity
    • 21 CFR 111.70(b)(2): Specifications-component purity, strength, composition
    • 21 CFR 111.70(b)(3): Specifications - contamination limits
    • 21 CFR 111.70(d): Specifications - labels, packaging
    • 21 CFR 111.70(e): Specifications - identity, purity, strength, composition

    Source: FDA Data Dashboard – Citations (FEI 1811396, inspection ID 1210540)

  5. 21 Jul 2023
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Food/Cosmetics. Project area(s): Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 1210540)

  6. 28 Aug 2019
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 820.75(a): Lack of or inadequate process validation
    • 21 CFR 820.90(a): Nonconforming product, Lack of or inadequate procedures

    Source: FDA Data Dashboard – Citations (FEI 1811396, inspection ID 1101180)

  7. 28 Aug 2019
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 1101180)

  8. 22 Feb 2019
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.166(a): Written program not followed

    Source: FDA Data Dashboard – Citations (FEI 1811396, inspection ID 1080109)

  9. 22 Feb 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 1811396, inspection ID 1080109)

  10. 14 Jun 2018
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.110(a): Written in-process control procedures
    • 21 CFR 211.113(a): Procedures for non-sterile drug products
    • 21 CFR 211.192: Quality control unit review of records
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 1811396, inspection ID 1056856)

  11. 14 Jun 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 1811396, inspection ID 1056856)

  12. 25 Mar 2016
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring; Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 967738)

  13. 30 Dec 2013
    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 1811396, inspection ID 863755)

  14. 21 Jun 2012
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Food/Cosmetics. Project area(s): Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 787532)

  15. 29 Mar 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 1811396, inspection ID 716697)

  16. 06 Mar 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 1811396, inspection ID 567605)

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.