Fresenius Kabi Usa, Llc
United States See location details
Last FDA Action:
Oct 13, 2023
This drug manufacturing facility is registered with the FDA by Fresenius Kabi Usa, Llc. ProPublica was able to identify at least 156 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.
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13
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.
10
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.
- Oct 13, 2023Oct 13, 2023Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.2 citations
Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 30, 2023Aug 30, 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 NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 12, 2019Aug 12, 2019Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 29, 2018Jun 29, 2018
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 NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 30, 2017Mar 30, 2017Inspection With Issues
The FDA determined this facility was in an acceptable state, though an inspector documented issues.
The FDA ultimately considered the facility to be in an acceptable state of compliance, which is the best possible outcome for an inspection. It’s impossible to know exactly what happened in this case, but an inspector filed a 483 report documenting issues, possibly as a part of a concurrent inspection that we don’t have an outcome for.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Feb 1, 2017Feb 1, 2017Inspection 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 4, 2016Feb 4, 2016Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.5 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Scientifically sound laboratory controlsLaboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 6, 2015Mar 6, 2015
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 NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 24, 2014Oct 24, 2014Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.3 citations
Buildings of Suitable Size, Construction, LocationBuildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.Representative Samples CriteriaThe number of containers to be sampled is not based upon appropriate criteria.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jan 11, 2013Jan 11, 2013Inspection 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.8 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Sanitation--buildings not clean, free of infestationBuildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.Written procedures not established/followedWritten procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 29, 2011Aug 29, 2011Inspection 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. - Jul 8, 2011Jul 8, 2011Inspection 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. - Jan 13, 2010Jan 13, 2010Inspection 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 followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Supervisor Training/Education/ExperienceIndividuals responsible for supervising the manufacture, processing, packing, and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Sep 17, 2009Sep 17, 2009Inspection 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 5, 2009Mar 5, 2009Inspection
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. - Oct 31, 2008Oct 31, 2008Inspection
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.
CompanyFresenius Kabi Usa
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-dose (10mL)
NDC: 63323-325-X
CompanyFresenius Kabi Usa
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-dose (10mL)
NDC: 63323-325-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a vial, single-use (2mL)
NDC: 51662-1632-1
CompanyHenry Schein
Dosage
3mg/mL
Injection, solution in a vial, single-use (2mL)
NDC: 0404-9993-02
CompanyFresenius Kabi Usa
Dosage
3mg/mL
Injection, solution in a vial, single-use (2mL)
NDC: 63323-651-X
CompanyFresenius Kabi Usa
Dosage
3mg/mL
Injection, solution in a vial, single-dose (20mL)
NDC: 63323-651-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a syringe (2mL)
NDC: 51662-1643-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
3mg/mL
Injection, solution in a vial, single-use (4mL)
NDC: 51662-1450-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Amiodarone Hydrochloride
50mg/mL
Injection, solution in a vial, single-dose (3mL)
NDC: 51662-1363-1
CompanyFresenius Kabi Usa
Dosage
50mg/mL
Injection, solution in a vial, single-dose (3mL)
NDC: 65219-643-X
CompanyFresenius Kabi Usa
Dosage
50mg/mL
Injection, solution in a vial, single-dose (9mL)
NDC: 65219-645-X
CompanyMedical Purchasing Solutions
Dosage
50mg/mL
Injection, solution in a vial, single-dose (3mL)
NDC: 71872-7034-1
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