Merz Pharmaceuticals GmbH
⚠️ High Risk
FEI: 3005043162 • Frankfurt Am Main, Hassia • GERMANY
FEI Number
3005043162
Location
Frankfurt Am Main, Hassia
Country
GERMANYAddress
Eckenheimer Landstr. 100, , Frankfurt Am Main, Hassia, 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/26/2025 | 58PCY05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 11/10/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 2/5/2025 | 58PCP05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2024 | 58PCR02INCOBOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 6/4/2024 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 5/21/2024 | 58PCZ05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2024 | 58PCY05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 4/30/2024 | 58PCY05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 6/24/2022 | 65QCZ02BOTOX | Division of Southeast Imports (DSEI) | |
| 12/6/2021 | 65QAY02BOTOX | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2021 | 65QCZ02BOTOX | Division of West Coast Imports (DWCI) | |
| 7/2/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/11/2020 | 65QCZ02BOTOX | Division of Northern Border Imports (DNBI) | |
| 5/20/2020 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 1/21/2020 | 65ACY04MEMANTINE HCI | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 5/15/2018 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/20/2014 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Cincinnati District Office (CIN-DO) | |
| 8/15/2014 | 65QCZ02BOTOX | Cincinnati District Office (CIN-DO) | |
| 8/27/2012 | 61LBJ08HEPARIN SODIUM (ANTI-COAGULANT) | San Francisco District Office (SAN-DO) | |
| 10/13/2011 | 61LDJ30HEPARIN CALCIUM (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/28/2011 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/27/2006 | 61HBJ99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/13/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/15/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/20/2002 | 60TCA99ANTAGONIST, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Merz Pharmaceuticals GmbH's FDA import refusal history?
Merz Pharmaceuticals GmbH (FEI: 3005043162) has 27 FDA import refusal record(s) in our database, spanning from 3/20/2002 to 11/26/2025.
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. Merz Pharmaceuticals GmbH's FEI number is 3005043162.
What types of violations has Merz Pharmaceuticals GmbH received?
Merz Pharmaceuticals GmbH has been cited for 14 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 Merz Pharmaceuticals GmbH come from?
All FDA import refusal data for Merz Pharmaceuticals 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.