Jubilant Hollisterstier General Partnership
This drug manufacturing facility is registered with the FDA by Jubilant Hollisterstier General Partnership. ProPublica was able to identify at least 4 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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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.
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.
- Jun 14, 2024Jun 14, 2024Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Feb 28, 2023Feb 28, 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. - Oct 7, 2022Oct 7, 2022Inspection
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 1, 2018Jun 1, 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.2 citations
Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.Annual visual exams of drug productsReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 10, 2015Dec 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 26, 2013Sep 26, 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.4 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination.Written procedures not established/followedWritten procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 26, 2012Mar 26, 2012Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 11, 2010Feb 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. - Feb 5, 2009Feb 5, 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.
CompanyJubilant Draximage
Dosage
Albumin Aggregated
2.5mg
Injection, powder, for solution in a kit (30)
NDC: 65174-270-30
CompanyBausch & Lomb Americas
Dosage
2.5%
Solution/ drops in a bottle, dropper (15mL)
NDC: 82260-102-X
CompanyBausch & Lomb Americas
Dosage
2.5%
Solution/ drops in a bottle, dropper (5mL)
NDC: 82260-103-05
CompanyJubilant Draximage (usa)
Dosage
Technetium Tc-99m Sestamibi
1mg/mL
Injection, powder, for solution in a vial (10mL)
NDC: 45548-141-X