Patheon Manufacturing Services Llc
United States See location details
Last FDA Action:
May 24, 2024
This drug manufacturing facility is registered with the FDA by Patheon Manufacturing Services Llc. ProPublica was able to identify at least 23 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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13
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.
- May 24, 2024May 24, 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. - Feb 23, 2024Feb 23, 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
Following/documenting laboratory controlsEstablished laboratory control mechanisms are not followed and documented at the time of performance.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 4, 2022Aug 4, 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
Buildings of Suitable Size, Construction, LocationBuildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.Extent of discrepancy, failure investigationsInvestigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 14, 2020Aug 14, 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. - May 17, 2019May 17, 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. - Jul 17, 2018Jul 17, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Apr 20, 2017Apr 20, 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. - Nov 18, 2016Nov 18, 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. - Dec 17, 2015Dec 17, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.3 citations
Actual vs. theoretical yields not determinedActual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.Storage under appropriate conditionsDrug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.Following/documenting laboratory controlsEstablished laboratory control mechanisms are not followed and documented at the time of performance.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Sep 12, 2014Sep 12, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Apr 11, 2014Apr 11, 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. - Jan 25, 2013Jan 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. - Apr 20, 2012Apr 20, 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. - Apr 21, 2011Apr 21, 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. - Jun 18, 2010Jun 18, 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. - Sep 2, 2009Sep 2, 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.
CompanyOceanside Pharmaceuticals
Dosage
25mg
White oval tablet marked with VRX 205 EDECRIN
NDC: 68682-011-10
CompanyHf Acquisition Co Llc, Dba Healthfirst
Dosage
Hyaluronidase (human Recombinant)
150USP/mL
Injection, solution in a vial (1mL)
NDC: 51662-1555-1
CompanyA-s Medication Solutions
Dosage
Hyaluronidase (human Recombinant)
150USP/mL
Injection, solution in a vial (1mL)
NDC: 50090-4534-0
CompanyAntares Pharma
Dosage
Hyaluronidase (human Recombinant)
150USP/mL
Injection, solution in a vial (1mL)
NDC: 18657-117-X
CompanyPrasco Laboratories
Dosage
750mg
White round tablet, chewable marked with S405 750
NDC: 66993-423-X
CompanyPrasco Laboratories
Dosage
1,000mg
White round tablet, chewable marked with S405 1000
NDC: 66993-424-X
CompanyPrasco Laboratories
Dosage
500mg
White round tablet, chewable marked with S405 500
NDC: 66993-422-X
CompanyPiramal Critical Care
Dosage
Morphine Sulfate
500mg/20mL
Injection in a vial, single-use (1mL)
NDC: 66794-162-02
CompanyPiramal Critical Care
Dosage
Morphine Sulfate
200mg/20mL
Injection in a vial, single-use (1mL)
NDC: 66794-160-02
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
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