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Resilience — West Chester

West Chester, Ohio, United States · CDMO

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

Site facts

Company
Resilience
Name(s) in FDA data
Resilience US, LLC
FEI number(s)
3006316363 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
West Chester, Ohio, United States 45011
Records matched
14 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
21 Jan 2025 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …West Chester, Ohio Sterile Drug Product Manufacturing Our commercially licensed site takes drug product from formulation through…
  • Clinical trial supply & packaging
    …ion devices Device platforms Autoinjectors, pens, accessorized and safety-device syringes Packaging Six packaging bays, with labeling, serialization, and aggregation across bulk, multi-unit…
  • Analytical testing
    …single-unit configurations Testing In-house analytical and micro testing for release and stability Storage Ambient and cold chain down to -80°C, in a 100,000-square-foot cold-chain warehouse From…

Taken from the company's web page for this site. Source: https://resilience.com/facilities-west-chester, 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. 21 Jan 2025
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.194(a)(8): Identification of Person Performing Review of Lab Records
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.84(d)(6): Microbiological Contamination Exam

    Source: FDA Data Dashboard – Citations (FEI 3006316363, inspection ID 1258820)

  2. 21 Jan 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 3006316363, inspection ID 1258820)

  3. 09 Aug 2019
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3006316363, inspection ID 1099149)

  4. 08 Mar 2018
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3006316363, inspection ID 1043914)

  5. 08 Mar 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 3006316363, inspection ID 1043914)

  6. 07 Sep 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 3006316363, inspection ID 1028106)

  7. 27 Jun 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 3006316363, inspection ID 1018002)

  8. 24 Aug 2016
    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 3006316363, inspection ID 983420)

  9. 03 Nov 2015
    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 3006316363, inspection ID 951936)

  10. 28 Jul 2015
    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 3006316363, inspection ID 936336)

  11. 22 Jul 2014
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(a): Following/documenting laboratory controls
    • 21 CFR 211.67(b): Written procedures not established/followed
    • 21 CFR 314.81(b)(1)(i): Mix-up

    Source: FDA Data Dashboard – Citations (FEI 3006316363, inspection ID 889585)

  12. 22 Jul 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 3006316363, inspection ID 889585)

  13. 09 Apr 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 3006316363, inspection ID 826470)

  14. 11 Jul 2012
    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 3006316363, inspection ID 790132)

  15. 15 Oct 2010
    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 3006316363, inspection ID 685058)

  16. 29 Jan 2010
    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 3006316363, inspection ID 643288)

  17. 23 Dec 2009
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006316363, inspection ID 636149)

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.