Vetter Pharma Fertigung Gmbh & Co. Kg (ravensburg Mooswiesen)
Germany See location details
Last FDA Action:
Mar 19, 2024
This drug manufacturing facility is registered with the FDA by Vetter Pharma Fertigung Gmbh & Co. Kg. ProPublica was able to identify at least 7 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.
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.
- Mar 19, 2024Mar 19, 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. - 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 26, 2022Aug 26, 2022
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. - Jul 20, 2020Jul 20, 2020Inspection 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. - Jul 17, 2019Jul 17, 2019
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 12, 2018Jun 12, 2018Inspection
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 9, 2018Feb 9, 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. - Nov 2, 2017Nov 2, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jul 26, 2016Jul 26, 2016Inspection
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. - Dec 5, 2014Dec 5, 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.1 citation
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Oct 28, 2013Oct 28, 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. - Jul 20, 2012Jul 20, 2012Inspection
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 1, 2010Apr 1, 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.
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.
CompanyJanssen Biotech
Dosage
Daratumumab
100mg/5mL
Injection, solution, concentrate in a vial (5mL)
NDC: 57894-502-X
CompanyJanssen Biotech
Dosage
Daratumumab
100mg/5mL
Colorless to yellow injection, solution, concentrate in a vial, single-dose (5mL)
NDC: 57894-505-X
CompanyBioverativ Therapeutics
Dosage
Sutimlimab
50mg/mL
Injection, solution, concentrate in a vial, single-dose (22mL)
NDC: 80203-347-01
CompanyJanssen Biotech
Dosage
Nipocalimab
185mg/mL
Colorless to slightly brownish injection, solution, concentrate in a vial, single-dose (6.5mL)
NDC: 57894-801-01
CompanyJanssen Biotech
Dosage
Nipocalimab
185mg/mL
Colorless to slightly brownish injection, solution, concentrate in a vial, single-dose (1.62mL)
NDC: 57894-800-01
CompanyGalderma Laboratories, L.p.
Dosage
Nemolizumab
30mg/100mg
Injection, powder, lyophilized, for solution in a syringe (30mg)
NDC: 0299-6220-X
CompanyArgenx Us
Dosage
Efgartigimod Alfa
20mg/mL
Injection in a vial, single-dose (20mL)
NDC: 73475-3041-5