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Fresenius Kabi Austria

Austria See location details
Last FDA Action: Mar 21, 2024

This drug manufacturing facility is registered with the FDA by Fresenius Kabi Austria. ProPublica was able to identify at least 22 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
9 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.

7 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.

  • Mar 21, 2024
    Mar 21, 2024
    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.
  • Mar 28, 2023
    Mar 28, 2023

    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.
  • Oct 13, 2022
    Oct 13, 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.
  • Jan 30, 2020
    Jan 30, 2020
    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.
  • Feb 8, 2018
    Feb 8, 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.
  • Mar 17, 2017
    Mar 17, 2017
    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
    Computerized records
    Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.
    Environmental Monitoring System
    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
    Cleaning / Sanitizing / Maintenance
    Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 19, 2015
    Jun 19, 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.
    2 citations
    Written record of investigation incomplete
    Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
    Sample identification and other information
    Laboratory records do not include a description of the sample received for testing, the quantity of the sample, the lot number or other distinctive code of the sample, the date the sample was taken, and the date the sample was received for testing.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 16, 2013
    Jul 16, 2013
    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.
  • Mar 25, 2011
    Mar 25, 2011
    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.
  • Jul 3, 2009
    Jul 3, 2009
    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.

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.

Adenosine

CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a vial, single-use (2mL)
NDC: 51662-1632-1

Adenosine

CompanyFresenius Kabi Usa
Dosage
3mg/mL
Injection, solution in a syringe, plastic (2mL)
NDC: 63323-651-X

Adenosine

CompanyHenry Schein
Dosage
3mg/mL
Injection, solution in a vial, single-use (2mL)
NDC: 0404-9993-02

Adenosine

CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a syringe (2mL)
NDC: 51662-1643-X

Adenosine

CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a vial, single-use (4mL)
NDC: 51662-1450-X

Ephedrine Sulfate

CompanyFresenius Kabi Usa
Dosage
5mg/mL
Injection in a syringe, plastic (5mL)
NDC: 65219-546-X

Ephedrine Sulfate

CompanyFresenius Kabi Usa
Dosage
5mg/mL
Injection in a syringe, plastic (10mL)
NDC: 65219-548-X

Foscarnet

CompanyFresenius Kabi Usa
Dosage
Foscarnet Sodium
24mg/mL
Injection, solution in a bottle (250mL)
NDC: 63323-875-50

Icatibant

CompanyFresenius Kabi Usa
Dosage
Icatibant Acetate
10mg/mL
Injection, solution in a syringe (3mL)
NDC: 63323-574-X

Leucovorin Calcium

CompanyFresenius Kabi Usa
Dosage
10mg/mL
Injection in a vial, single-use (50mL)
NDC: 63323-631-50

Leucovorin Calcium

CompanyFresenius Kabi Usa
Dosage
10mg/mL
Injection in a vial, single-use (10mL)
NDC: 63323-631-10

Palonosetron

CompanyFresenius Kabi Usa
Dosage
Palonosetron Hydrochloride
0.25mg/5mL
Injection, solution in a syringe, plastic (5mL)
NDC: 63323-673-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].