Directory › Cambrex

Cambrex — Paullo

Paullo, Italy · CDMO

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

Site facts

Company
Cambrex
Name(s) in FDA data
Cambrex Profarmaco Milano Srl
FEI number(s)
3003723076 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Paullo, Italy
Records matched
8 FDA inspections · 1 warning letter
Most recent FDA inspection in dataset
11 Nov 2022 — NAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …02 345988300 reception@cambrex.com Previous Next 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Generic API Manufacturing Advanced Intermediates and Derivatives 70+ API Library FDA | AIFA | PMDA |…
  • Analytical testing
    …lities. The facility also features a comprehensive pilot plant and custom development and analytical laboratories. Facility Details 7 commercial-scale cGMP production departments 1 cGMP pilot pl…

Taken from the company's web page for this site. Source: https://www.cambrex.com/locations/paullo-milan-italy/, 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. 11 Nov 2022
    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 3003723076, inspection ID 1193220)

  2. 01 Oct 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 3003723076, inspection ID 1167505)

  3. 07 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 3003723076, inspection ID 1091698)

  4. 19 May 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 3003723076, inspection ID 1021644)

  5. 06 Nov 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 3003723076, inspection ID 973972)

  6. 06 Dec 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3003723076, inspection ID 861141)

  7. 25 Mar 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 3003723076, inspection ID 723863)

  8. 12 Aug 2009
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 3003723076; case/injunction ID 73425.

    Source: FDA Data Dashboard – Compliance Actions (FEI 3003723076, case 73425)

  9. 31 Mar 2009
    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 3003723076, inspection ID 575657)

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.