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Lonza — Tampa

Tampa, Florida, United States · CDMO

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

Site facts

Company
Lonza
Name(s) in FDA data
Lonza Tampa LLC
FEI number(s)
3001549109 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Tampa, Florida, United States 33634
Records matched
6 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 Aug 2025 — VAI

Capabilities (from the company's website)

  • Oral solid dose
    …Lonza’s global Contract Development and Manufacturing (CDMO) network. For an overview of Capsules & Health Ingredients sites, please visit the Capsules & Health Ingredients locations page…

Taken from the company's web page for this site. Source: https://www.lonza.com/about-us/our-locations/tampa-fl-usa, 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. 22 Aug 2025
    Form 483 observations 9 posted Form 483 citation(s)

    Citation summaries (9)
    • 21 CFR 211.110(c): In-process materials characteristics testing
    • 21 CFR 211.113(a): Procedures for non-sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.46(b): Equipment for Environmental Control
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance
    • 21 CFR 211.67(b)(1): Cleaning SOP/responsibility
    • 21 CFR 211.67(c): Cleaning/maintenance records not kept
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 3001549109, inspection ID 1279220)

  2. 22 Aug 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 3001549109, inspection ID 1279220)

  3. 29 Sep 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3001549109, inspection ID 1219089)

  4. 29 Sep 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 3001549109, inspection ID 1219089)

  5. 01 Oct 2021
    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 3001549109, inspection ID 1153431)

  6. 20 Jul 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 3001549109, inspection ID 1059866)

  7. 14 Jul 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 3001549109, inspection ID 1017944)

  8. 10 Dec 2008
    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 3001549109, inspection ID 551193)

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.