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Curia — Rensselaer

Rensselaer, New York, 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 York, Inc.
FEI number(s)
1310298 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Rensselaer, New York, United States 12144
Records matched
8 FDA inspections · 1 warning letter
Most recent FDA inspection in dataset
05 Feb 2026 — OAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …Skip to content Curia – Rensselaer, NY, USA Highly potent and controlled API manufacturing, from lab scale to roughly 180,000 L of commercial capacity. Curia’s Rensse…
  • Highly potent (HPAPI)
    …Skip to content Curia – Rensselaer, NY, USA Highly potent and controlled API manufacturing, from lab scale to roughly 180,000 L of commercial capac…
  • Analytical testing
    …le I-V compounds Rensselaer is licensed for Schedule I-V controlled substances, including analytical testing and DEA-approved storage, giving sponsors a single regulated site for development, manufa…
  • Controlled substances
    …laer site capabilities overview Rensselaer site capabilities overview What this site does Controlled substances Licensed for Schedule I-V compounds Rensselaer is licensed for Schedule I-V controlled s…

Taken from the company's web page for this site. Source: https://curiaglobal.com/facilities/rensselaer-ny/, 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. 18 Sep 2026
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 1310298; case/injunction ID 728790. Letter subject: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).

    Source: FDA warning letter (fda.gov) · FDA Data Dashboard – Compliance Actions (FEI 1310298, case 728790)

  2. 05 Feb 2026
    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 1310298, inspection ID 1305832)

  3. 01 Nov 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 1310298, inspection ID 1221790)

  4. 09 Nov 2017
    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 1310298, inspection ID 1035437)

  5. 22 May 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 1310298, inspection ID 927304)

  6. 15 Jan 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 1310298, inspection ID 863460)

  7. 30 Jan 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 1310298, inspection ID 816479)

  8. 29 Mar 2012
    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 1310298, inspection ID 777773)

  9. 07 Apr 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 1310298, inspection ID 661993)

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.