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Afton Scientific — Charlottesville

Charlottesville, Virginia, United States · CDMO

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

Site facts

Company
Afton Scientific
Name(s) in FDA data
Afton Scientific, LLC
FEI number(s)
1000123236 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Charlottesville, Virginia, United States 22902
Records matched
10 FDA inspections · 7 inspections with posted 483 citations
Most recent FDA inspection in dataset
08 May 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Your Success is Our Success Explore Our Expertise Trusted Leaders in Pharmaceutical Aseptic Manufacturing For over 20 years, Afton Scientific has provided pharmaceutical companies with industr…
  • Small molecule
    …ical companies with industry-leading expertise in aseptic manufacturing for biologics and small molecules. Robust regulatory compliance and FDA(CBER & CDER)-inspected facilities Cutting-edge tech…
  • Analytical testing
    …ge of your product lifecycle. Explore Afton Scientific’s advanced lab services, including analytical testing, stability studies, quality control, validation, and customized investigations. Discover…

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.aftonscientific.com/, 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. 08 May 2024
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.56(a): Sanitation--buildings not clean, free of infestation
    • 21 CFR 211.67(b): Written procedures not established/followed
    • 21 CFR 211.84(d)(3): Establish reliability of supplier's C of A

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 1237992)

  2. 08 May 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000123236, inspection ID 1237992)

  3. 06 Oct 2023
    Form 483 observations 8 posted Form 483 citation(s)

    Citation summaries (8)
    • 21 CFR 117.135(c)(3): Sanitation preventive controls - Appropriate (Adequate)
    • 21 CFR 117.410(c): Supply-chain program - Assurance (Adequate)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.142(b): Storage under appropriate conditions
    • 21 CFR 211.160(b)(3): Drug products - samples representative, identified properly
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 1219743)

  4. 06 Oct 2023
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Food/Cosmetics. Project area(s): Foodborne Biological Hazards; Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000123236, inspection ID 1219743)

  5. 06 Apr 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 1000123236, inspection ID 1202143)

  6. 14 Jun 2019
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.142(b): Storage under appropriate conditions
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.194(a)(1): Sample identification and other information
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.42(c)(10): Aseptic Processing Area

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 1092986)

  7. 14 Jun 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 1000123236, inspection ID 1092986)

  8. 15 Sep 2017
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 1025744)

  9. 15 Sep 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000123236, inspection ID 1025744)

  10. 01 May 2015
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.100(a): Changes to Procedures Not Reviewed, Approved
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.165(f): Failing drug products not rejected

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 924691)

  11. 01 May 2015
    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 1000123236, inspection ID 924691)

  12. 25 Apr 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.42(c)(10)(iii): Air Supply

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 875687)

  13. 25 Apr 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 1000123236, inspection ID 875687)

  14. 24 Jun 2013
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.113(b): Procedures for sterile drug products

    Source: FDA Data Dashboard – Citations (FEI 1000123236, inspection ID 837211)

  15. 24 Jun 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 1000123236, inspection ID 837211)

  16. 26 Sep 2011
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000123236, inspection ID 746549)

  17. 20 Mar 2009
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000123236, inspection ID 573864)

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.