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PPD (Thermo Fisher Scientific) — Middleton

Middleton, Wisconsin, United States · Testing lab

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

Site facts

Company
PPD (Thermo Fisher Scientific)
Name(s) in FDA data
PPD Development, L.P.
FEI number(s)
2129896 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Middleton, Wisconsin, United States 53562
Records matched
8 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
01 May 2026 — NAI

Capabilities (from the company's website)

  • Analytical testing
    …ons and services Our GMP lab provides comprehensive drug substance / drug product (DS/DP) analytical testing with first-time accuracy. As a leading provider of chemistry, manufacturing and controls…
  • Microbiology
    …alized expertise in mass spectroscopy Potency bioassay and molecular biology applications Microbiology CMC advisory services Impurity identification and characterization Qualified person (QP)…

Taken from a company-level page; the company does not publish a separate page for this site, so tags may describe the wider organisation. Source: https://www.ppd.com/our-solutions/ppd-laboratories/gmp-lab/, 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. 01 May 2026
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 2129896, inspection ID 1320960)

  2. 25 Sep 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.46(b): Equipment for Environmental Control

    Source: FDA Data Dashboard – Citations (FEI 2129896, inspection ID 1284012)

  3. 25 Sep 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 2129896, inspection ID 1284012)

  4. 16 Jul 2021
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 2129896, inspection ID 1146503)

  5. 19 Sep 2019
    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 2129896, inspection ID 1105196)

  6. 18 May 2018
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 2129896, inspection ID 1056412)

  7. 20 Nov 2013
    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 2129896, inspection ID 855964)

  8. 09 Nov 2011
    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 2129896, inspection ID 754321)

  9. 24 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 2129896, inspection ID 599791)

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.