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Patheon Italia S.p.a

Italy See location details
Last FDA Action: Jun 14, 2022

This drug manufacturing facility is registered with the FDA by Patheon Manufacturing Services Llc. ProPublica was able to identify at least 19 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
11 Known Inspections

The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.

8 Inspections Found Issues

When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.

  • Jun 14, 2022
    Jun 14, 2022
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Feb 25, 2022
    Feb 25, 2022
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 21, 2018
    Sep 21, 2018
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 31, 2016
    Oct 31, 2016
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Sep 7, 2016
    Sep 7, 2016

    An inspector documented issues at the facility.

    We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 16, 2015
    Dec 16, 2015
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 19, 2015
    May 19, 2015
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 31, 2013
    Oct 31, 2013
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 21, 2013
    Jun 21, 2013
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    6 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Cleaning/maintenance records not kept
    Records are not kept for the maintenance, cleaning, and inspection of equipment.
    Reports of Analysis (Components)
    Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Nov 11, 2011
    Nov 11, 2011
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 30, 2011
    May 30, 2011
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 22, 2009
    Jun 22, 2009
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
50mg/10mL
Injection in a vial, single-use (10mL)
NDC: 66658-505-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
100mg/4mL
Injection in a vial, single-use (4mL)
NDC: 66658-523-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
500mg/20mL
Injection in a vial, single-use (20mL)
NDC: 66658-525-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
10mg/2mL
Injection in a vial, single-use (2mL)
NDC: 66658-501-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
100mg/20mL
Injection in a vial, single-use (20mL)
NDC: 66658-510-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
50mg/2mL
Injection in a vial, single-use (2mL)
NDC: 66658-522-01

Gamifant

CompanySwedish Orphan Biovitrum Ab (publ)
Dosage
Emapalumab
250mg/10mL
Injection in a vial, single-use (10mL)
NDC: 66658-524-01

Iomeron

CompanyBracco Diagnostics
Dosage
Iomeprol
510mg/mL
Yellow injection, solution in a bottle, glass (100mL)
NDC: 0270-7250-10

Iomeron

CompanyBracco Diagnostics
Dosage
Iomeprol
612mg/mL
Yellow injection, solution in a bottle, glass (100mL)
NDC: 0270-7300-X

Iomeron

CompanyBracco Diagnostics
Dosage
Iomeprol
612mg/mL
Yellow injection, solution in a bottle, glass (500mL)
NDC: 0270-9300-06

Iomeron

CompanyBracco Diagnostics
Dosage
Iomeprol
816mg/mL
Yellow injection, solution in a bottle, glass (500mL)
NDC: 0270-9400-X

Iomeron

CompanyBracco Diagnostics
Dosage
Iomeprol
714mg/mL
Yellow injection, solution in a bottle, glass (100mL)
NDC: 0270-7350-X

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].