Amgen, Inc
United States See location details
Last FDA Action:
Aug 7, 2025
This drug manufacturing facility is registered with the FDA by Amgen, Inc. ProPublica was able to identify at least 13 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
22
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.
6
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.
- Aug 7, 2025Aug 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. - Mar 13, 2025Mar 13, 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.4 citations
Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.Acceptance of in-process materialsDeterminations of conformance to appropriate written specifications for acceptance are not made for in-process materials.No written record of investigationWritten records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Feb 6, 2024Feb 6, 2024
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 14, 2023Sep 14, 2023Inspection
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. - Dec 13, 2019Dec 13, 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.1 citation
Cleaning SOP/inspectionProcedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 16, 2018Mar 16, 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. - May 16, 2017May 16, 2017
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. - Apr 19, 2017Apr 19, 2017Inspection
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 19, 2017Apr 19, 2017Inspection
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 17, 2017Mar 17, 2017Inspection
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 17, 2017Feb 17, 2017
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 1, 2016Sep 1, 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. - Jun 6, 2016Jun 6, 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 NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Apr 13, 2016Apr 13, 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. - Feb 12, 2016Feb 12, 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. - May 22, 2015May 22, 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. - Nov 14, 2014Nov 14, 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. - Sep 17, 2014Sep 17, 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. - Aug 27, 2014Aug 27, 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. - Jul 25, 2013Jul 25, 2013Inspection
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. - Dec 12, 2012Dec 12, 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. - Dec 12, 2012Dec 12, 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.8 citations
Failure to develop written proceduresWritten procedures have not been developed for the receipt and reporting to FDA of post marketing adverse drug experiences.Failure by applicant to report ADEAdverse drug experience information has not been reported to FDA.Late submission of 15-day reportNot all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 12, 2012Dec 12, 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. - May 20, 2011May 20, 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. - Nov 17, 2010Nov 17, 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. - Jun 3, 2010Jun 3, 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.1 citation
Late submission of 15-day reportNot all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - May 1, 2009May 1, 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.
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.
CompanyAmgen Usa
Dosage
Adalimumab
40mg/0.4mL
Injection in a syringe (0.4mL)
NDC: 72511-479-02
CompanyAmgen Usa
Dosage
Adalimumab
40mg/0.8mL
Injection in a syringe (0.8mL)
NDC: 72511-400-X
CompanyAmgen Usa
Dosage
Adalimumab
40mg/0.4mL
Injection in a syringe (0.4mL)
NDC: 72511-482-X
CompanyAmgen Usa
Dosage
Adalimumab
20mg/0.2mL
Injection in a syringe (0.2mL)
NDC: 72511-399-01
CompanyAmgen Usa
Dosage
Adalimumab
80mg/0.8mL
Injection in a syringe (0.8mL)
NDC: 72511-481-02
CompanyAmgen
Dosage
Infliximab
100mg/10mL
Injection, powder, lyophilized, for solution in a vial, single-dose (10mL)
NDC: 55513-670-X
CompanyJanssen Products, Lp
Dosage
Epoetin
4,000IU/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 59676-304-X
CompanyJanssen Products, Lp
Dosage
Epoetin
10,000IU/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 59676-310-X
CompanyJanssen Products, Lp
Dosage
Epoetin
2,000IU/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 59676-302-X
CompanyJanssen Products, Lp
Dosage
Epoetin
40,000IU/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 59676-340-X
CompanyJanssen Products, Lp
Dosage
Epoetin
10,000IU/mL
Injection, solution in a vial, multi-dose (2mL)
NDC: 59676-312-X
CompanyJanssen Products, Lp
Dosage
Epoetin
3,000IU/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 59676-303-X
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