Merz Pharma GmbH & Co., KGaA
⚠️ High Risk
FEI: 3006896175 • Dessau-Rosslau • GERMANY
FEI Number
3006896175
Location
Dessau-Rosslau
Country
GERMANYAddress
Am Pharmapark, , Dessau-Rosslau, , 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 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).
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 |
|---|---|---|---|
| 1/22/2026 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 1/13/2025 | 58PCK05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 10/7/2022 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 12/27/2013 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New Orleans District Office (NOL-DO) | |
| 12/27/2013 | 80KYZSYRINGE, IRRIGATING | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Merz Pharma GmbH & Co., KGaA's FDA import refusal history?
Merz Pharma GmbH & Co., KGaA (FEI: 3006896175) has 5 FDA import refusal record(s) in our database, spanning from 12/27/2013 to 1/22/2026.
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 Pharma GmbH & Co., KGaA's FEI number is 3006896175.
What types of violations has Merz Pharma GmbH & Co., KGaA received?
Merz Pharma GmbH & Co., KGaA 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 Merz Pharma GmbH & Co., KGaA come from?
All FDA import refusal data for Merz Pharma GmbH & Co., KGaA 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.