Denk Pharma GmbH & Co. KG
⚠️ High Risk
FEI: 3012791190 • Munich, Bavaria • GERMANY
FEI Number
3012791190
Location
Munich, Bavaria
Country
GERMANYAddress
Prinzregentenstr. 79, , Munich, Bavaria, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2025 | 54YGA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2021 | 61FCY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 61XCB99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2019 | 56ECA22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2017 | 61PCB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 54YCA04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54ABA15VITAMIN D2 (CALCIFEROL) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54ABA15VITAMIN D2 (CALCIFEROL) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54CYC99PROTEIN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54BBA01CALCIUM (MINERAL) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCY02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54BBY08MAGNESIUM (MINERAL) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54BBY08MAGNESIUM (MINERAL) | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2016 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/18/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2016 | 62ODA29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2016 | 66SCA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Denk Pharma GmbH & Co. KG's FDA import refusal history?
Denk Pharma GmbH & Co. KG (FEI: 3012791190) has 25 FDA import refusal record(s) in our database, spanning from 10/17/2016 to 4/11/2025.
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. Denk Pharma GmbH & Co. KG's FEI number is 3012791190.
What types of violations has Denk Pharma GmbH & Co. KG received?
Denk Pharma GmbH & Co. KG 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 Denk Pharma GmbH & Co. KG come from?
All FDA import refusal data for Denk Pharma 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.