Pfizer Manufacturing Deutschland GmbH
⚠️ High Risk
FEI: 3002807097 • Freiburg Im Breisgau, Baden-Wurttemberg • GERMANY
FEI Number
3002807097
Location
Freiburg Im Breisgau, Baden-Wurttemberg
Country
GERMANYAddress
Pfizer Gmbh Arzneimittelwerk Godecke, Mooswaldallee 1, Freiburg Im Breisgau, 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).
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 |
|---|---|---|---|
| 11/13/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 10/22/2025 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2025 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 62GCB90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 61LDY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 61LDY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2024 | 61LCB44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2024 | 61LDY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2024 | 61WDY38TRIACETIN (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2024 | 61LDY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2024 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/1/2023 | 61LDA99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2023 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2018 | 62IIE99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/20/2018 | 62IIE99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/2/2016 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/13/2015 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2012 | 64RCK21SOMATROPIN (HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/24/2011 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/19/2010 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/14/2008 | 61MIE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/21/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/14/2005 | 61JCY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/3/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/23/2002 | 61JBC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Pfizer Manufacturing Deutschland GmbH's FDA import refusal history?
Pfizer Manufacturing Deutschland GmbH (FEI: 3002807097) has 27 FDA import refusal record(s) in our database, spanning from 12/23/2002 to 11/13/2025.
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. Pfizer Manufacturing Deutschland GmbH's FEI number is 3002807097.
What types of violations has Pfizer Manufacturing Deutschland GmbH received?
Pfizer Manufacturing Deutschland GmbH has been cited for 3 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 Pfizer Manufacturing Deutschland GmbH come from?
All FDA import refusal data for Pfizer Manufacturing Deutschland GmbH 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.