Hospira, Inc.
United States See location details
Last FDA Action:
Jan 17, 2025
This drug manufacturing facility is registered with the FDA by Hospira, Inc.. ProPublica was able to identify at least 127 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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17
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.
- Jan 17, 2025Jan 17, 2025Inspection 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
Control procedures to monitor and validate performanceControl procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.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. - Mar 27, 2024Mar 27, 2024Inspection
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. - Jun 30, 2023Jun 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. - Jan 17, 2020Jan 17, 2020Inspection 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.10 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Exhaust systems inadequate to control air contaminationAdequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.SOPs not followed / documentedWritten production and process control procedures are not followed in the execution of production and process control functions.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 15, 2018Aug 15, 2018Inspection 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 27, 2017Oct 27, 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. - Jun 8, 2016Jun 8, 2016Inspection 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. - Apr 3, 2015Apr 3, 2015Inspection 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. - Apr 23, 2014Apr 23, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 16, 2013Aug 16, 2013Inspection 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 24, 2012Oct 24, 2012Inspection 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 25, 2012May 25, 2012Inspection
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. - Jan 4, 2012Jan 4, 2012Inspection 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 25, 2011May 25, 2011Inspection
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. - May 5, 2011May 5, 2011Inspection
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. - Apr 16, 2010Apr 16, 2010Inspection
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. - Aug 27, 2009Aug 27, 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. - Apr 9, 2009Apr 9, 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. - Aug 30, 2007Aug 30, 2007
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. - Sep 12, 2002Sep 12, 2002
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.
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.
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Lidocaine Hydrochloride
5mg/mL
Injection, solution in a vial, single-dose (50mL)
NDC: 51662-1600-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Lidocaine Hydrochloride
10mg/mL
Injection, solution in a vial, multi-dose (20mL)
NDC: 51662-1465-1
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Lidocaine Hydrochloride
10mg/mL
Injection, solution in a vial, multi-dose (50mL)
NDC: 51662-1466-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Lidocaine Hydrochloride
20mg/mL
Injection, solution in a vial, multi-dose (20mL)
NDC: 51662-1467-1
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Lidocaine Hydrochloride
20mg/mL
Injection, solution in a vial, multi-dose (50mL)
NDC: 51662-1326-X
CompanyHospira
Dosage
0.3mg/mL
Injection, solution in a cartridge (1mL)
NDC: 0409-2012-X
CompanyHospira
Dosage
2mg/mL
Injection, solution in a vial, single-dose (5mL)
NDC: 0409-5547-X
CompanyHospira
Dosage
2mg/mL
Injection, solution in a vial, multi-dose (10mL)
NDC: 0409-7083-X
CompanyHospira
Dosage
2mg/mL
Injection, solution in a vial, single-dose (5mL)
NDC: 0409-1098-X
CompanyHospira
Dosage
10mg/mL
Injection, solution in a vial, single-dose (20mL)
NDC: 0409-3670-X
CompanyHospira
Dosage
10mg/mL
Injection, solution in a vial, single-dose (20mL)
NDC: 0409-1103-X
CompanyHospira
Dosage
2mg/mL
Injection, solution in a vial, multi-dose (10mL)
NDC: 0409-1208-X
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