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Solvias — Kaiseraugst

Kaiseraugst, Switzerland · Testing lab

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

Site facts

Company
Solvias
Name(s) in FDA data
Solvias AG
FEI number(s)
3008735083 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Kaiseraugst, Switzerland
Records matched
10 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
07 Aug 2025 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …ith Us Kaiseraugst Solvias Headquarters and Center of Excellence with a Wide Range of CMC Analytical Services Located in the Greater Basel Area, our Kaiseraugst site is a growing center for biotech i…
  • Microbiology
    …herapeutics Our specialized capabilities in cell-based bioassays , molecular biology, and microbiological testing, are each supported by dedicated lab space, expert teams, and expanding portf…
  • Biosafety & viral testing
    …ency Assays for Cell and Gene Therapy Development Read More Webinars & Videos Update your biosafety testing of biologics Read More Close…
  • Extractables & leachables
    …S, HPLC, and NMR, we deliver data aligned with IND, NDA, and BLA regulatory requirements. Extractables & Leachables Testing Solvias’ Extractables & Leachables (E&L) Testing ensures the safety…
  • Medical device testing
    …tractables & Leachables (E&L) Testing ensures the safety of drug products, biologics, and medical devices by detecting harmful substances from packaging and delivery systems. With 20+ years of e…

Taken from the company's web page for this site. Source: https://www.solvias.com/about-us/centers-of-excellence/kaiseraugst/, 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. 07 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 3008735083, inspection ID 1339406)

  2. 01 Sep 2023
    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 3008735083, inspection ID 1219962)

  3. 09 Jun 2023
    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 3008735083, inspection ID 1210338)

  4. 22 Nov 2022
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b)(4): Calibration - at intervals, written program, remedial action
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3008735083, inspection ID 1193131)

  5. 22 Nov 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 3008735083, inspection ID 1193131)

  6. 27 Oct 2017
    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 3008735083, inspection ID 1036580)

  7. 07 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 3008735083, inspection ID 873203)

  8. 04 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 3008735083, inspection ID 871241)

  9. 08 Apr 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 3008735083, inspection ID 729142)

  10. 24 Jun 2010
    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 3008735083, inspection ID 673196)

  11. 04 Nov 2008
    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 3008735083, inspection ID 548070)

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.