Sanofi Pasteur Inc.
United States See location details
Last FDA Action:
Aug 2, 2024
This drug manufacturing facility is registered with the FDA by Sanofi Pasteur Inc.. ProPublica was able to identify at least 2 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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9
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.
- Aug 2, 2024Aug 2, 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.1 citation
input/output verificationInput to and output from the computer are not checked for accuracy.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Apr 22, 2023Apr 22, 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.3 citations
Air SupplyAseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.Equipment Design, Size and LocationEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.Cleaning / Sanitizing / MaintenanceEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 26, 2018Oct 26, 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. - Jun 15, 2018Jun 15, 2018Inspection 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. - Jun 22, 2016Jun 22, 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. - May 9, 2014May 9, 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 18, 2012Aug 18, 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 21, 2010May 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. - Nov 5, 2009Nov 5, 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. - Apr 21, 2009Apr 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.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.