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Bora Pharmaceuticals — Baltimore

Baltimore, Maryland, 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 Injectables Inc
FEI number(s)
1000512361 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Baltimore, Maryland, United States 21230
Records matched
15 FDA inspections · 6 inspections with posted 483 citations · 1 warning letter
Most recent FDA inspection in dataset
25 Jul 2024 — NAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Sterile Injectable CDMO Facility in Baltimore, MD Our 87,000 square foot cGMP facility in Baltimore, MD, USA…
  • Lyophilization
    …exible and scalable fill/finish solutions for vials and pre-filled syringes in liquid and lyophilized formats. With decades of experience in clinical and commercial production, our facility…
  • Small molecule
    …te has extensive experience in tech transfer, scale-up, and commercial production of both small molecules and biological compounds, and is capable of filling viscous and non-viscous solutions/sus…
  • Clinical trial supply & packaging
    …ring services for sterile injectables, specializing in aseptic fill/finish manufacturing, packaging, analytical services, and on-site testing and support services for clinical and commercia…
  • Analytical testing
    …es for sterile injectables, specializing in aseptic fill/finish manufacturing, packaging, analytical services, and on-site testing and support services for clinical and commercial drug products. This…

Taken from the company's web page for this site. Source: https://boracdmo.com/locations/baltimore-md/, 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. 25 Jul 2024
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 1236852)

  2. 10 Aug 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 1000512361, inspection ID 1215798)

  3. 10 Aug 2022
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 1000512361; case/injunction ID 630316. Letter subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Division of Pharmaceutical Quality Operations I.

    Source: FDA warning letter (fda.gov) · FDA Data Dashboard – Compliance Actions (FEI 1000512361, case 630316)

  4. 18 Feb 2022
    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 1000512361, inspection ID 1162959)

  5. 16 Apr 2021
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.182: Written records kept in individual logs
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.84(e): Rejecting When Specifications Not Met

    Source: FDA Data Dashboard – Citations (FEI 1000512361, inspection ID 1140286)

  6. 16 Apr 2021
    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 1000512361, inspection ID 1140286)

  7. 10 May 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 1000512361, inspection ID 1091850)

  8. 13 Jun 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 1056814)

  9. 20 Dec 2016
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.194(a)(8): Second person sign off

    Source: FDA Data Dashboard – Citations (FEI 1000512361, inspection ID 997766)

  10. 20 Dec 2016
    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 1000512361, inspection ID 997766)

  11. 28 Aug 2015
    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 1000512361, inspection ID 950170)

  12. 28 Aug 2015
    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 1000512361, inspection ID 950170)

  13. 26 Aug 2014
    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 211.84(d)(2): Reports of Analysis (Components)

    Source: FDA Data Dashboard – Citations (FEI 1000512361, inspection ID 893672)

  14. 26 Aug 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 1000512361, inspection ID 893672)

  15. 09 Apr 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.100(a): Absence of Written Procedures

    Source: FDA Data Dashboard – Citations (FEI 1000512361, inspection ID 873904)

  16. 09 Apr 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 1000512361, inspection ID 873904)

  17. 01 Aug 2012
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.100(b): Procedure Deviations Recorded and Justified

    Source: FDA Data Dashboard – Citations (FEI 1000512361, inspection ID 792496)

  18. 01 Aug 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 1000512361, inspection ID 792496)

  19. 22 Jul 2011
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Drugs. Project area(s): Blood and Blood Products; Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 735256)

  20. 27 Aug 2010
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics, Devices, Drugs. Project area(s): Compliance: Devices; Drug Quality Assurance; Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 678345)

  21. 20 Oct 2009
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 626826)

  22. 27 Aug 2009
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices, Drugs. Project area(s): Compliance: Devices; Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1000512361, inspection ID 608105)

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.