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Delpharm — Boucherville

Boucherville, Canada · CDMO

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

Site facts

Company
Delpharm
Name(s) in FDA data
Delpharm Boucherville Canada, Inc.
FEI number(s)
3000280957 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Boucherville, Canada
Records matched
7 FDA inspections · 2 inspections with posted 483 citations · 1 warning letter
Most recent FDA inspection in dataset
26 Jan 2024 — VAI

Capabilities (from the company's website)

  • Oral liquids & semi-solids
    …ites for the North American market. With extensive expertise covering sterile, liquid and semi-solid forms, as well as a solid grasp of regulatory analysis, our teams will support you in int…

Taken from the part of the company's network/locations page that describes this site. Source: https://www.delpharm.com/en/our-sites/north-america/, 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. 26 Jan 2024
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.42(c): Defined areas of adequate size for operations
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3000280957, inspection ID 1228759)

  2. 26 Jan 2024
    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 3000280957, inspection ID 1228759)

  3. 11 Feb 2020
    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 3000280957, inspection ID 1121358)

  4. 12 Jun 2018
    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 3000280957, inspection ID 1057031)

  5. 09 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 3000280957, inspection ID 982638)

  6. 22 Oct 2013
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.186(b)(7): Theoretical yield statement including percentages
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done
    • 21 CFR 314.81(b)(1)(ii): Contamination, chemical or physical change, deterioration

    Source: FDA Data Dashboard – Citations (FEI 3000280957, inspection ID 855260)

  7. 22 Oct 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 3000280957, inspection ID 855260)

  8. 18 Nov 2011
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 3000280957; case/injunction ID 233134.

    Source: FDA Data Dashboard – Compliance Actions (FEI 3000280957, case 233134)

  9. 04 Aug 2011
    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 3000280957, inspection ID 743413)

  10. 15 Jul 2009
    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 3000280957, inspection ID 606017)

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.