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Bora Pharmaceuticals — Mississauga

Mississauga, Canada · CDMO

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

Site facts

Company
Bora Pharmaceuticals
Name(s) in FDA data
Bora Pharmaceutical Services Inc.
FEI number(s)
3002807086 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Mississauga, Canada
Records matched
10 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
28 Jan 2025 — VAI

Capabilities (from the company's website)

  • Oral solid dose
    …ms offer expert development, manufacturing, packaging, and commercialization services for oral solid dose (OSD), liquid, and semi-solid therapeutics. Explore our Mississauga capabilities Con…
  • Oral liquids & semi-solids
    …cturing, packaging, and commercialization services for oral solid dose (OSD), liquid, and semi-solid therapeutics. Explore our Mississauga capabilities Connect with our team to discuss your…
  • Inhalation & nasal
    …primary and secondary packaging capabilities for tablets, capsules, liquids (suspensions, nasal sprays, etc.), and semi-solids (creams, lotions, gels, ointments). Capabilities Pilot Pla…
  • Clinical trial supply & packaging
    …headquarters, Bora contract manufacturing teams offer expert development, manufacturing, packaging, and commercialization services for oral solid dose (OSD), liquid, and semi-solid therape…

Taken from the company's web page for this site. Source: https://boracdmo.com/locations/mississauga-on/, 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. 28 Jan 2025
    Form 483 observations 9 posted Form 483 citation(s)

    Citation summaries (9)
    • 21 CFR 211.122(a): Written procedures not followed
    • 21 CFR 211.125(a): Strict control not exercised over labeling issued
    • 21 CFR 211.165(a): Testing and release for distribution
    • 21 CFR 211.166(a)(4): Testing in same container - closure system
    • 21 CFR 211.166(a): Written program not followed
    • 21 CFR 211.188(b)(11): Identification of persons involved, each significant step
    • 21 CFR 211.192: Quality control unit review of records
    • 21 CFR 211.194(d): Laboratory equipment calibration records
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 3002807086, inspection ID 1259373)

  2. 28 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 3002807086, inspection ID 1259373)

  3. 07 Nov 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 3002807086, inspection ID 1116737)

  4. 22 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 3002807086, inspection ID 1030562)

  5. 24 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 3002807086, inspection ID 937006)

  6. 21 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 3002807086, inspection ID 937000)

  7. 25 Sep 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 3002807086, inspection ID 852228)

  8. 15 Aug 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 3002807086, inspection ID 742880)

  9. 16 Jul 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 3002807086, inspection ID 683123)

  10. 10 Dec 2008
    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 3002807086, inspection ID 556934)

  11. 10 Dec 2008
    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 3002807086, inspection ID 554914)

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.