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Bora Pharmaceuticals — Maple Grove

Maple Grove, Minnesota, United States · CDMO

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

Site facts

Company
Bora Pharmaceuticals
Name(s) in FDA data
Bora Pharmaceuticals Inc.
FEI number(s)
3004106442 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Maple Grove, Minnesota, United States 55369
Records matched
15 FDA inspections · 4 inspections with posted 483 citations · 1 warning letter
Most recent FDA inspection in dataset
03 Nov 2022 — NAI

Capabilities (from the company's website)

  • Oral solid dose
    …experts are dedicated to the formulation, development, and manufacturing of high-quality oral solid dosage forms, powders, liquids, and suspensions. Explore our Maple Grove capabilities Con…
  • Clinical trial supply & packaging
    …additional 100,000 square feet available for future expansion. This site is equipped with serialization and aggregation capabilities and offers comprehensive contract manufacturing services. Ou…
  • Analytical testing
    …ouses robust quality control laboratories and a dedicated R&D team to support product and analytical development as well as innovation. Capabilities Oral solid dosage Powders Liquids Suspensions R & D D…

Taken from the company's web page for this site. Source: https://boracdmo.com/locations/maple-grove-mn/, 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. 03 Nov 2022
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Food/Cosmetics. Project area(s): Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 1191488)

  2. 30 Aug 2022
    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 3004106442, inspection ID 1178557)

  3. 19 Dec 2018
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 111.65: Quality control - quality, dietary supplement
    • 21 CFR 211.182: Personnel dating/signing equipment log
    • 21 CFR 211.188(b)(3): Identification of each component or in-process material
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.67(b)(2): Cleaning SOPs/schedules

    Source: FDA Data Dashboard – Citations (FEI 3004106442, inspection ID 1075922)

  4. 19 Dec 2018
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls

    Source: FDA Data Dashboard – Citations (FEI 3004106442, inspection ID 1075923)

  5. 19 Dec 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Food/Cosmetics. Project area(s): Drug Quality Assurance; Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 1075922)

  6. 19 Dec 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Food/Cosmetics. Project area(s): Drug Quality Assurance; Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 1075923)

  7. 21 Jun 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 1057809)

  8. 10 Dec 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 3004106442, inspection ID 957263)

  9. 10 Dec 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 3004106442, inspection ID 957264)

  10. 03 Mar 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures

    Source: FDA Data Dashboard – Citations (FEI 3004106442, inspection ID 869641)

  11. 03 Mar 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Food/Cosmetics. Project area(s): Bioresearch Monitoring; Drug Quality Assurance; Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 869641)

  12. 01 Mar 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 3004106442, inspection ID 822477)

  13. 01 Mar 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 3004106442, inspection ID 822479)

  14. 28 Feb 2011
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.130(e): Packaging line inspection after use
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.25(a): Training , Education , Experience overall

    Source: FDA Data Dashboard – Citations (FEI 3004106442, inspection ID 711370)

  15. 28 Feb 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 3004106442, inspection ID 711370)

  16. 22 Feb 2011
    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 3004106442, inspection ID 711848)

  17. 19 Jan 2011
    Warning letter FDA warning letter (Food/Cosmetics)

    Compliance action recorded by FDA for FEI 3004106442; case/injunction ID 143733.

    Source: FDA Data Dashboard – Compliance Actions (FEI 3004106442, case 143733)

  18. 08 Oct 2010
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Food/Cosmetics. Project area(s): Bioresearch Monitoring; Drug Quality Assurance; Food Composition, Standards, Labeling and Econ.

    Source: FDA Data Dashboard – Inspections (FEI 3004106442, inspection ID 684684)

  19. 29 Sep 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 3004106442, inspection ID 684686)

  20. 02 Oct 2008
    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 3004106442, inspection ID 539836)

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.