Hospira, Inc.
United States See location details
Last FDA Action:
Feb 7, 2025
This drug manufacturing facility is registered with the FDA by Hospira, Inc.. ProPublica was able to identify at least 224 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.
- Feb 7, 2025Feb 7, 2025Inspection
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. - Nov 14, 2023Nov 14, 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. - Nov 21, 2019Nov 21, 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.3 citations
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.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.Written record of investigation incompleteWritten 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Feb 2, 2018Feb 2, 2018Inspection 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.4 citations
Calibration/Inspection/Checking not doneRoutine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.Procedure Deviations Recorded and JustifiedDeviations from written production and process control procedures are not recorded and justified.Test devices not meeting specificationsTest devices are deficient in that instruments not meeting established specifications are used.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - May 26, 2016May 26, 2016Inspection
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 24, 2015Sep 24, 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. - Jun 13, 2014Jun 13, 2014Inspection
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 1, 2013Mar 1, 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.20 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.Temperature / Humidity ControlsAseptic processing areas are deficient regarding temperature controls.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 4, 2011Aug 4, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.3 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.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.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. - Jun 17, 2011Jun 17, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.17 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training--operations, GMPs, written proceduresEmployees are not given training in the particular operations they perform as part of their function.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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jan 19, 2010Jan 19, 2010Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.6 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.In-process materials specificationsIn-process specifications are not determined by the application of suitable statistical procedures where appropriate.Process control proceduresProcess control procedures that describe any process controls necessary to ensure conformance to specifications were not established and implemented.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 21, 2009Aug 21, 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.3 citations
Procedure Deviations Recorded and JustifiedDeviations from written production and process control procedures are not recorded and justified.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.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.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.
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Bupivacaine Hydrochloride
2.5mg/mL
Injection, solution in a vial, multi-dose (50mL)
NDC: 51662-1606-X
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
CompanyHf Acquisition Co. Llc, Dba Health First
Dosage
Lidocaine Hydrochloride
20mg/mL
Injection, solution in a syringe, plastic (5mL)
NDC: 51662-1231-X
CompanyHf Acquisition Co. Llc, Dba Health First
Dosage
Magnesium Sulfate Heptahydrate
500mg/mL
Injection, solution in a syringe, plastic (10mL)
NDC: 51662-1235-X
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Sodium Bicarbonate
75mg/mL
Injection, solution in a syringe (50mL)
NDC: 51662-1463-1
CompanyHf Acquisition Co. Llc, Dba Healthfirst
Dosage
Sodium Bicarbonate
84mg/mL
Injection, solution in a vial, glass (50mL)
NDC: 51662-1256-X
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