Drug factory · FDA FEI 3002808846
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)
Eisenbahnstrasse 2-4, Langenargen, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 20, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept | Makes it and tests it | Regeneron Pharmaceuticals, Inc. | 61755-005 |
| Daratumumab | Tests it | Janssen Biotech, Inc. | 57894-502 |
| Efanesoctocog Alfa | Makes it and tests it | Bioverativ Therapeutics Inc. | 71104-978, 71104-979, 71104-981 +3 |
| Efmoroctocog Alfa | Tests it | Bioverativ Therapeutics Inc. | 71104-801, 71104-802, 71104-803 +7 |
| Eftrenonacog Alfa | Makes it and tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Fitusiran | Makes it and tests it | Genzyme Corporation | 58468-0347, 58468-0348 |
| Japanese Encephalitis Virus Strain Sa 14-14-2 Antigen (formaldehyde Inactivated) | Tests it | Vetter Pharma Fertigung GmbH & Co. KG | 62195-051 |
| Lumasiran | Makes it and tests it | Alnylam Pharmaceuticals, Inc. | 71336-1002 |
| Nipocalimab | Makes it and tests it | Janssen Biotech, Inc. | 57894-800, 57894-801 |
| Susoctocog Alfa | Makes it | Takeda Pharmaceuticals America, Inc. | 0944-5001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 20, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Feb 20, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 17, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 26, 2016 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; manufacture.