Catalent Pharma Solutions, Llc
United States See location details
Last FDA Action:
May 24, 2024
This drug manufacturing facility is registered with the FDA by Catalent Pharma Solutions 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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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.
5
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.
- May 24, 2024May 24, 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
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. - Dec 15, 2022Dec 15, 2022Inspection 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
Following/documenting laboratory controlsEstablished laboratory control mechanisms are not followed and documented at the time of performance.Establishment of calibration proceduresProcedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.Test methodsThe accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Sep 28, 2020Sep 28, 2020Inspection 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.5 citations
Design plans - Lack of or inadequateDesign plans that describe or reference the design and development activities and define responsibility for implementation have not been adequately established.Design input - Lack of or inadequate proceduresProcedures for design input have not been adequately established.Design output - Lack of or inadequate proceduresProcedures for design output have not been established.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 20, 2019Dec 20, 2019Inspection
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 4, 2019Mar 4, 2019Inspection 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. - Feb 1, 2019Feb 1, 2019Inspection
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 19, 2017May 19, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.2 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Released Drug Products AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 20, 2015Mar 20, 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. - Feb 14, 2013Feb 14, 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. - Nov 11, 2010Nov 11, 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. - Nov 18, 2009Nov 18, 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.
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
90mcg
Aerosol, metered in a inhaler (200)
NDC: 51662-1513-1
CompanyProficient Rx Lp
Dosage
90mcg
Aerosol, metered in a inhaler (200)
NDC: 71205-441-85