Merz North America, Inc.
⚠️ High Risk
FEI: 3003407669 • Franksville, WI • UNITED STATES
FEI Number
3003407669
Location
Franksville, WI
Country
UNITED STATESAddress
4133 Courtney Rd Ste 10, , Franksville, WI, United States
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
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 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).
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.
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 6/26/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 6/16/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/13/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/11/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 12/20/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 4/9/2024 | 60QAL07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/15/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/8/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/10/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/23/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 6/22/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 5/31/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 5/1/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Northern Border Imports (DNBI) |
| 9/7/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/16/2016 | 65QCK02BOTOX | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/16/2016 | 65QCK02BOTOX | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Merz North America, Inc.'s FDA import refusal history?
Merz North America, Inc. (FEI: 3003407669) has 21 FDA import refusal record(s) in our database, spanning from 3/16/2016 to 11/19/2025.
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 North America, Inc.'s FEI number is 3003407669.
What types of violations has Merz North America, Inc. received?
Merz North America, Inc. has been cited for 9 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 North America, Inc. come from?
All FDA import refusal data for Merz North America, Inc. 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.