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Resilience — Mississauga

Mississauga, Canada · CDMO

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

Site facts

Company
Resilience
Name(s) in FDA data
Resilience Biotechnologies, Inc.
FEI number(s)
3007503037 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Mississauga, Canada
Records matched
4 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
10 Nov 2023 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …arby locations in the Greater Toronto Area, running 24/7 across multiple shifts Molecules Monoclonal antibodies, recombinant proteins, plasma-derived biologics, nanoparticles, and other complex prod…
  • Highly potent (HPAPI)
    …wing on extensive expertise across complex modalities. Our team additionally provides non-cytotoxic chemical and enzymatic conjugation services. 04 Formulation and Aseptic Vial Filling Drug…
  • Analytical testing
    …cal line running batches up to 5,000 units Testing On-site chemistry and microbiology QC; analytical method development, qualification, and validation; and ICH-compliant stability programs, across…
  • Microbiology
    …units and a clinical line running batches up to 5,000 units Testing On-site chemistry and microbiology QC; analytical method development, qualification, and validation; and ICH-compliant stab…
  • Formulation & process development
    …gics Development & Manufacturing Toronto is our center of excellence for biologics, where process development, drug substance manufacturing, and aseptic vial filling are all seamlessly combined insid…

Taken from the company's web page for this site. Source: https://resilience.com/facilities-toronto, 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. 10 Nov 2023
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3007503037, inspection ID 1222580)

  2. 10 Nov 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 3007503037, inspection ID 1222580)

  3. 28 Aug 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 3007503037, inspection ID 1100759)

  4. 26 Jul 2013
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3007503037, inspection ID 843453)

  5. 17 Jul 2012
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3007503037, inspection ID 790000)

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.