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Cambrex — Charles City

Charles City, Iowa, United States · CDMO

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

Site facts

Company
Cambrex
Name(s) in FDA data
Cambrex Charles City, Inc.
FEI number(s)
1000119390 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Charles City, Iowa, United States 50616
Records matched
8 FDA inspections · 1 recall
Most recent FDA inspection in dataset
07 Mar 2025 — VAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …x: +1 641-228-4152 Previous Next 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 350,000 L Commercial API Capacity Late Phase & Commercial API Manufacturing API Process Optimization & Scale Up HP…
  • Highly potent (HPAPI)
    …PI Capacity Late Phase & Commercial API Manufacturing API Process Optimization & Scale Up HPAPI & Controlled Substances DEA-registered Facility Overview Our 400+ team members in Charles…
  • Analytical testing
    …cGMP pilot plant 1 cGMP kilo laboratory 350,000 L commercial capacity R&D development and analytical laboratories Validated commercial continuous flow technology at large scale Controlled substa…
  • Formulation & process development
    …13 14 15 350,000 L Commercial API Capacity Late Phase & Commercial API Manufacturing API Process Optimization & Scale Up HPAPI & Controlled Substances DEA-registered Facility Overview Our 400+ team m…
  • Controlled substances
    …ity Late Phase & Commercial API Manufacturing API Process Optimization & Scale Up HPAPI & Controlled Substances DEA-registered Facility Overview Our 400+ team members in Charles City have strong exper…

Taken from the company's web page for this site. Source: https://www.cambrex.com/locations/charles-city-ia-usa/, 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. 07 Mar 2025
    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 1000119390, inspection ID 1266564)

  2. 02 May 2022
    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 1000119390, inspection ID 1169072)

  3. 22 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 1000119390, inspection ID 1009802)

  4. 20 May 2014
    Recall Class II drug recall D-0447-2017 (Terminated)

    Recalling firm: Cambrex Charles City Inc, Charles City. Reason: Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. Product: Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg

    Source: openFDA drug enforcement report (Recall D-0447-2017; FDA report date 2017-02-01)

  5. 27 Feb 2014
    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 1000119390, inspection ID 868083)

  6. 02 Aug 2013
    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 1000119390, inspection ID 843001)

  7. 28 Feb 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 1000119390, inspection ID 768805)

  8. 26 Mar 2010
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Food/Cosmetics, Veterinary. Project area(s): Drug Quality Assurance; Foodborne Biological Hazards; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000119390, inspection ID 653275)

  9. 08 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 1000119390, inspection ID 540696)

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.