Vetter Pharma Fertigung GmbH & Co. KG
⚠️ High Risk
FEI: 3002270322 • Ravensburg, Baden-wurttemberg • GERMANY
FEI Number
3002270322
Location
Ravensburg, Baden-wurttemberg
Country
GERMANYAddress
Schutzenstr. 87/99-101, , Ravensburg, Baden-wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58HCY06DULAGLUTIDE | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/12/2023 | 62GCK99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/5/2020 | 80LZGPUMP, INFUSION, INSULIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 65FCI04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | New Orleans District Office (NOL-DO) | |
| 6/19/2012 | 64MCP99GONAD-STIMULATING PRINCIPLE N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/15/2012 | 64MDA11GANIRELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/15/2012 | 64MCA07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2012 | 64MCA11GANIRELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 79LMFAGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED | New Orleans District Office (NOL-DO) | |
| 10/31/2011 | 66SCZ45ALPROSTADIL (VASODILATOR) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 10/31/2011 | 66SCP45ALPROSTADIL (VASODILATOR) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/31/2005 | 61LCP27DALTEPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/20/2005 | 61LCP27DALTEPARIN SODIUM (ANTI-COAGULANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vetter Pharma Fertigung GmbH & Co. KG's FDA import refusal history?
Vetter Pharma Fertigung GmbH & Co. KG (FEI: 3002270322) has 15 FDA import refusal record(s) in our database, spanning from 5/20/2005 to 9/3/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Vetter Pharma Fertigung GmbH & Co. KG's FEI number is 3002270322.
What types of violations has Vetter Pharma Fertigung GmbH & Co. KG received?
Vetter Pharma Fertigung GmbH & Co. KG has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Vetter Pharma Fertigung GmbH & Co. KG come from?
All FDA import refusal data for Vetter Pharma Fertigung GmbH & Co. KG is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.