Lonza Houston Inc.
United States See location details
Last FDA Action:
Mar 7, 2024
This drug manufacturing facility is registered with the FDA by Lonza Biologics Inc. ProPublica was able to identify at least 6 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
8
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.
- Jul 12, 2024Jul 12, 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. - Mar 7, 2024Mar 7, 2024Inspection 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. - Jul 21, 2023Jul 21, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 22, 2021Oct 22, 2021
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 3, 2020Nov 3, 2020
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 21, 2017Sep 21, 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. - Aug 26, 2016Aug 26, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 10, 2015Feb 10, 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. - Sep 30, 2013Sep 30, 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. - Apr 21, 2010Apr 21, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Sep 3, 2009Sep 3, 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.
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.
CompanyElusys Therapeutics
Dosage
Obiltoxaximab
100mg/mL
Solution in a vial, single-use (6mL)
NDC: 69604-204-02
CompanySanofi-aventis U.s
Dosage
Isatuximab
100mg/5mL
Injection, solution, concentrate in a vial, single-dose (5mL)
NDC: 0024-0654-01
CompanySanofi-aventis U.s
Dosage
Isatuximab
500mg/25mL
Injection, solution, concentrate in a vial, single-dose (25mL)
NDC: 0024-0656-01
CompanyArgenx Us
Dosage
Efgartigimod Alfa
20mg/mL
Injection in a vial, single-dose (20mL)
NDC: 73475-3041-5
CompanyArgenx Us
Dosage
Efgartigimod Alfa
180mg/mL
Hyaluronidase (human Recombinant)
2,000U/mL
Injection, solution in a vial, single-dose (5.6mL)
NDC: 73475-3102-3
CompanyArgenx Us
Dosage
Efgartigimod Alfa
200mg/mL
Hyaluronidase (human Recombinant)
2,000U/mL
Injection, solution in a syringe, glass (5mL)
NDC: 73475-1221-X