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Curia — Albuquerque

Albuquerque, New Mexico, United States · CDMO

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

Site facts

Company
Curia
Name(s) in FDA data
Curia New Mexico, LLC
FEI number(s)
1643045 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Albuquerque, New Mexico, United States 87107
Records matched
10 FDA inspections · 5 inspections with posted 483 citations
Most recent FDA inspection in dataset
28 Jun 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Skip to content Curia – Albuquerque, NM, USA Commercial sterile fill-finish offering flexibility across vials, syringes and cartridges. Curia’s Albuquerque facility…
  • Lyophilization
    …al line loss. High-speed vial filling Large-scale commercial vial filling with integrated lyophilization The new isolator-based line can handle 1,000 L batches and run at speeds up to 400 v…
  • Biologics drug substance
    …es and biologics Capabilities span small molecules, proteins, peptides, oligonucleotides, monoclonal antibodies, and more. BSL-2 formulation and filling infrastructure extends support for relevant b…
  • Small molecule
    …facility supports late-phase clinical and commercial manufacturing of sterile injectable small molecules and biologics in vials, prefilled syringes and cartridges. A $200 million expansion adds…
  • Peptides & oligonucleotides
    …cturing across small molecules and biologics Capabilities span small molecules, proteins, peptides, oligonucleotides, monoclonal antibodies, and more. BSL-2 formulation and filling infrast…
  • ADCs & bioconjugates
    …lopment and clinical vial manufacturing for complex and highly potent products, including ADCs. It extends Curia’s sterile drug product network for programs that need UK-based developm…
  • Clinical trial supply & packaging
    …d vial line supports up to 1,000 L batches with state-of-the-art automated inspection and labeling and packaging. Site investment $200M expansion Two isolated filling lines recently added…
  • Microbiology
    …bstances. QC to packaging In-house testing and downstream operations Full in-house QC and microbiology services, including sterility testing, sit alongside stability services. Visual inspecti…
  • Controlled substances
    …port for relevant biologic and vaccine programs for both liquid and lyophilized products. Controlled substances DEA registered facility with deep expertise handling controlled substances Albuquerque s…

Taken from the company's web page for this site. Source: https://curiaglobal.com/facilities/albuquerque-nm/, 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 Jun 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 1643045, inspection ID 1239282)

  2. 20 Mar 2020
    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 1643045, inspection ID 1121293)

  3. 07 Dec 2016
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.68(b): Backup data not assured as exact and complete

    Source: FDA Data Dashboard – Citations (FEI 1643045, inspection ID 999295)

  4. 07 Dec 2016
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1643045, inspection ID 999295)

  5. 05 Jun 2015
    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 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 1643045, inspection ID 929136)

  6. 05 Jun 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 1643045, inspection ID 929136)

  7. 17 Jul 2014
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.42(a): Buildings of Suitable Size, Construction, Location
    • 21 CFR 211.46(b): Equipment for Environmental Control

    Source: FDA Data Dashboard – Citations (FEI 1643045, inspection ID 887832)

  8. 17 Jul 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 1643045, inspection ID 887832)

  9. 23 Aug 2013
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.67(b): Written procedures fail to include

    Source: FDA Data Dashboard – Citations (FEI 1643045, inspection ID 846158)

  10. 23 Aug 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 1643045, inspection ID 846158)

  11. 19 Apr 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 1643045, inspection ID 779678)

  12. 16 Aug 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 1643045, inspection ID 740742)

  13. 12 Mar 2010
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.160(b)(4): Establishment of calibration procedures
    • 21 CFR 211.180(e)(2): Items to cover on annual reviews
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.80(a): Procedures To Be in Writing

    Source: FDA Data Dashboard – Citations (FEI 1643045, inspection ID 652784)

  14. 12 Mar 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 1643045, inspection ID 652784)

  15. 07 Nov 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 1643045, inspection ID 554098)

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.